FDA Registration Active 🇩🇪 Germany

AESCULAP AG

Reg #: 9610612 · FEI: 3002806315 · Expires 2026
Products
412
Proprietary Names
193
Establishment Types
6
Classifications
412

Registration Details

Registration Name
AESCULAP AG
Registration Number
9610612
FEI Number
3002806315
Status
Active
Expiry Year
2026
Initial Importer
No
Address
AM AESCULAP PLATZ
City
TUTTLINGEN, DONAU Baden-Wurttemberg
Country
DE

Regulatory Submissions

510(k) Number
K102081
PMA Number
P050013

Owner / Operator

Firm Name
Aesculap AG
Operator Number
8010193
Address
Am Aesculap-Platz
City
Tuttlingen
State
Baden-Wurttemberg
Postal Code
78532
Country
DE
Correspondent
Kamaal Anas

US Agent

Business Name
Aesculap, Inc.
Contact Name
Kamaal Anas
Address
3773 Corporate Parkway
City
Center Valley
State
PA
ZIP
18034
Country
US
Phone
610 9849071 ext. 5071

Products

Device Name Product Code
Needle, Suturing, Disposable GAB
Clip, Implantable FZP
Needle, Suturing, Reusable GDL
Template HWT
Curette, Nasal KAP
Snare, Ear JZD
Orthosis, Spinal Pedicle Fixation MNI
Thoracolumbosacral Pedicle Screw System NKB
Orthosis, Spondylolisthesis Spinal Fixation MNH
Appliance, Fixation, Spinal Interlaminal KWP
Holder, Needle, Gastroenterologic FHQ
Remover, Crown EIS
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented LPH
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented LZO
Needle, Aspiration And Injection, Disposable GAA
Stabilizer, Heart MWS
Insufflator, Laparoscopic HIF
Pneumoperitoneum Needle FHO
Guide, Surgical, Instrument FZX
Electrosurgical, Cutting & Coagulation & Accessories GEI
Instrument, Cast Removal, Ac-Powered LGH
Scissors, Nasal KBD
Clamp, Penile FHA
Retractor, Vaginal HDL
Elevator, Surgical, General & Plastic Surgery GEG
Drills, Burrs, Trephines & Accessories (Simple, Powered) HBE
Motor, Drill, Electric HBC
Applier, Aneurysm Clip HCI
Clamp, Wire, Orthodontic ECN
Tonsillectome KCA
Instrument, Measuring, Lens, Ac-Powered HLM
Clip, Aneurysm HCH
Needle, Tonsil Suturing KBR
Knife, Amputation GDN
Knife, Margin Finishing, Operative EJZ
Speculum, Rectal FFQ
Scaler, Periodontic EMN
Saw HSO
Retainer, Matrix JEP
Plate, Fixation, Bone HRS
Gauze/Sponge, Internal, X-Ray Detectable GDY
Unit, Heating, Powered IRQ
Knife, Tonsil KBQ
Screw, Fixation, Bone HWC
Forceps, Ophthalmic HNR
Appliance, Fixation, Spinal Intervertebral Body KWQ
Intervertebral Fusion Device With Bone Graft, Lumbar MAX
Shunt, Central Nervous System And Components JXG
Syringe, Irrigating (Non Dental) KYZ
Cannula, Ventricular HCD
Screwdriver HXX
Probe, Rectal, Non-Powered EXX
Mallet, Surgical, General & Plastic Surgery GFJ
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component KTT
Operating Room Accessories Table Tray FWZ
Catheter, Ventricular HCA
Retention Device, Suture KGS
Ligator, Hemorrhoidal FHN
Applicator, Ent KCJ
Adenotome KBH
Trocar, Sinus KBG
Excavator, Ear JYH
Motor, Drill, Pneumatic HBB
Endoscopic Video Imaging System/Component, Gastroenterology-Urology FET
Scalpel, One-Piece GDX
Instrument, Ent Manual Surgical LRC
Stylet, Surgical, General & Plastic Surgery GAH
Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented KWY
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented LWJ
Pump, Portable, Aspiration (Manual Or Powered) BTA
Retractor, Non-Self-Retaining FGN
Mirror, Mouth EAX
Clamp, Surgical, General & Plastic Surgery GDJ
Instrument, Microsurgical GZX
Unit, Electrosurgical, Endoscopic (With Or Without Accessories) KNS
Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment HWE
Sterilization Wrap Containers, Trays, Cassettes & Other Accessories KCT
Instrument, Cast Application/Removal, Manual LGG
Handle, Scalpel GDZ
Laryngoscope, Rigid CCW
Chisel, Middle-Ear JYE
Laparoscope, General & Plastic Surgery GCJ
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer JWH
Trephine HWK
Dilator, Esophageal, Ent KCF
Hook, Bone KIK
Forceps, Obstetrical HDA
Instrument, Manual, General Obstetric-Gynecologic KOH
Wrap, Sterilization FRG
Neurological Stereotaxic Instrument HAW
Bur, Surgical, General & Plastic Surgery GFF
Holder, Needle; Orthopedic HXK
Clamp, Rubber Dam EEF
Saw, Manual And Accessories GDR
Obturator, For Endoscope FEC
Mallet HXL
Saw, Electrically Powered DWI
Rongeur, Nasal KBB
Rongeur, Manual HAE
Twister, Wire HXS
Dilator, Cervical, Fixed Size HDQ
Probe, Ent KAK
Prosthesis, Intervertebral Disc MJO
Endoscope, Neurological GWG
Instrument, Shunt System Implantation GYK
Spinal Vertebral Body Replacement Device MQP
Headlamp, Operating, Battery-Operated HPP
Hook, Microsurgical Ear JYL
Scissors, Umbilical HDJ
Otoscope ERA
Loupe, Binocular, Low Power HJH
Needle, Ophthalmic Suturing HNM
Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate MEH
Instrument, Ultrasonic Surgical LFL
Fork, Tuning GWX
Orthosis, Spine, Plate, Laminoplasty, Metal NQW
Punch, Femoral Neck HWP
Instrument, Cutting, Orthopedic HTZ
Loupe, Diagnostic/Surgical FSP
Forceps, Biopsy, Gynecological HFB
Discriminator, Two-Point GWI
Knife, Surgical EMF
Cutter, Surgical FZT
Surgical Instruments, G-U, Manual (And Accessories) KOA
Scissors, Ophthalmic HNF
Elevator, Surgical, Dental EMJ
Holder, Speculum, Ent KAG
Rongeur HTX
Hammer, Surgical FZY
Tray, Surgical, Ent MMO
Curette HTF
Probe, Periodontic EIX
Dura Substitute GXQ
Pick, Microsurgical Ear JYT
Stethoscope, Fetal HGN
Wire, Orthodontic DZC
Electrocautery, Gynecologic (And Accessories) HGI
Cannula, Surgical, General & Plastic Surgery GEA
Extractor HWB
Microscope, Surgical, General & Plastic Surgery FSO
Anoscope And Accessories FER
Syringe, Periodontic, Endodontic, Irrigating EIC
Packer, Uterine HDM
Accessories, Retractor, Dental EIF
Table, Operating-Room, Manual FSE
Gag, Mouth KBN
Dissector, Tonsil KBM
Device, Locking, For Intestinal Clamp FFR
Ring, Laparotomy FHI
Stripper, Surgical HRT
Apparatus, Suction, Operating-Room, Wall Vacuum Powered GCX
Knife, Orthopedic HTS
Dilator, Nasal LWF
Cannula, Sinus KAM
Retractor, Self-Retaining FFO
Instrument, Manual, Specialized Obstetric-Gynecologic KNA
Drape, Surgical, Exempt PUI
Bone Mill LYS
Punch, Skull GXJ
Spatula, Surgical, General & Plastic Surgery GAF
Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer KRO
Reamer HTO
Caliper KTZ
Bender HXW
Clamp, Vascular DXC
Plate, Cranioplasty, Preformed, Non-Alterable GXN
Goniometer, Nonpowered KQW
Regulator, Vacuum KDP
Cable, Electrode IKD
Endoscopic Tissue Approximation Device OCW
Punch, Nasal KAY
Applier, Hemostatic Clip HBT
Forceps, General & Plastic Surgery GEN
Light, Headband, Surgical FSR
Dermatome GFD
Clamp, Umbilical HFW
Mirror, Headband, Ophthalmic HKF
Excavator, Dental, Operative EKC
Remover, Intrauterine Device, Contraceptive, Hook-Type HHF
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented JDI
Hoe, Periodontic EMQ
Expander, Surgical, Skin Graft FZW
Curette, Adenoid KBJ
Instruments, Surgical, Cardiovascular DWS
Unit, Examining/Treatment, Ent ETF
Cover, Burr Hole GXR
Forceps, Wire Holding HYA
Laparoscope, Gynecologic (And Accessories) HET
Probe And Director, Gastro-Urology FGM
Camera, Television, Surgical, With Audio FWC
Posterior Cervical Screw System NKG
Instrument, Cutting, Operative EKD
Tray, Surgical LRP
Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer MBH
Burnisher, Operative EKJ
Light, Examination, Medical, Battery Powered KYT
Rasp HTR
Scissors, Orthopedic, Surgical HRR
Probe HXB
Clip, Vascular DSS
Applier, Surgical, Clip GDO
Gauge, Depth HTJ
Clip, Scalp HBO
Knife, Ear JYO
Intervertebral Fusion Device With Bone Graft, Cervical ODP
Intervertebral Fusion Device With Integrated Fixation, Cervical OVE
Broach HTQ
Label Or Tag, Sterile LYV
Retractor GAD
Sterilizer, Steam FLE
Blade, Saw, Surgical, Cardiovascular DWH
Speculum, Ent EPY
Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer HRY
Device, Digital Image Storage, Radiological LMB
Camera, Television, Endoscopic, Without Audio FWF
Cannula, Injection FGY
Depressor, Metal Tongue, Surgical KBL
Starter, Bone Screw HWD
Tissue Adhesive For The Topical Approximation Of Skin MPN
Condenser, Amalgam And Foil, Operative EKG
File, Surgical, General & Plastic Surgery GEO
Cerclage, Fixation JDQ
Brace, Drill HXY
Guard, Instrument LXZ
Knife, Periodontic EMO
Pinwheel GWY
Apparatus, Suction, Single Patient Use, Portable, Nonpowered GCY
Motor, Surgical Instrument, Pneumatic Powered GET
Curette, Ear JYG
Chamber, Acoustic (For Audiometric Testing) EWC
Punch, Tonsil KBT
Chisel, Bone, Surgical EML
Forceps, Tooth Extractor, Surgical EMG
Knife, Ent KTG
Rasp, Surgical, General & Plastic Surgery GAC
Pliers, Operative EJY
File HTP
Battery, Replacement, Rechargeable MOQ
Tube, Laryngectomy KAC
Source, Carrier, Fiberoptic Light EQH
Syringe, Ent KCP
Instrument, Ligature Tucking, Orthodontic ECP
Driver, Surgical, Pin GFC
Drape, Surgical, Antimicrobial KKX
Knife, Nasal KAS
Instrument, Surgical, Non-Powered HAO
Speculum, Vaginal, Metal HDF
Forceps, Articulation Paper EFK
System, X-Ray, Angiographic IZI
Catheter, Eustachian, General & Plastic Surgery GBY
Pliers, Surgical HTC
Accessories, Arthroscopic NBH
Trocar, Ent KTE
Handpiece (Brace), Drill HBD
Unit, Suction Operatory EBR
Guide, Needle, Surgical GDF
Curette, Uterine HCY
Indicator, Physical/Chemical Sterilization Process JOJ
Marker, Skin FZZ
Hook, Surgical, General & Plastic Surgery GDG
Tamp HXG
Clamp, Non-Electrical FFN
Table, Operating-Room, Ac-Powered FQO
Sphyncteroscope FDR
Scissors, General, Surgical LRW
Spreader, Pulp Canal Filling Material, Endodontic EKK
File, Periodontic EMR
Passer HWQ
Osteotome HWM
Frame, Rubber Dam EJE
Chisel, Osteotome, Surgical EMM
Nipper, Malleus JYR
Needle, Dental DZM
Instrument, Contouring, Matrix, Operative EKF
Scissors, Collar And Crown EIR
Caliper, Ophthalmic HOE
Punch, Antrum KAW
Mirror, Ent KAI
Orthopedic Stereotaxic Instrument OLO
Explorer, Operative EKB
Corkscrew HWI
Awl HWJ
Catheter, Irrigation GBX
Amniotome HGE
Sound, Uterine HHM
Knife, Myringotomy JYP
Saw, Nasal KBC
Container, Liquid Medication, Graduated KYW
Accessories, Photographic, For Endoscope (Exclude Light Sources) FEM
Tray, Impression, Preformed EHY
Manual Instruments Designed For Use With Total Disc Replacement Devices QLQ
Fastener, Fixation, Biodegradable, Soft Tissue MAI
Sound, Urethral, Metal Or Plastic FBX
Retractor, Self-Retaining, For Neurosurgery GZT
Scissors, Wire Cutting, Ent, Sterile JYA
Tray, Surgical, Instrument FSM
Infusor, Pressure, For I.V. Bags KZD
Filler, Bone Void, Calcium Compound MQV
Saw, Pneumatically Powered KFK
Chisel, Surgical, Manual FZO
Rasp, Ear JYY
Syringe, Balloon Inflation MAV
Injector And Syringe, Angiographic DXT
Arthroscope HRX
Needle, Aspiration And Injection, Reusable GDM
Punch, Ent KTF
Table And Attachments, Operating-Room BWN
Instrument, Clip Removal HBQ
Headrest, Neurosurgical HBM
Curette, Surgical, Dental EMK
Chisel (Osteotome) KDG
Scoop FHL
Forceps, Rubber Dam Clamp EJG
Spinal Vertebral Body Replacement Device - Cervical PLR
Holder, Ear Speculum JYK
Camera, Surgical And Accessories KQM
Retractor, All Types EIG
Clamp HXD
Motor, Surgical Instrument, Ac-Powered GEY
Pusher, Socket HXO
Loop, Wire JYQ
Wrench HXC
Instrument, Compression HWN
Blower, Powder, Ent KCL
Applier, Staple, Surgical, GEF
Razor, Surgical LWK
Carver, Wax, Dental EIK
File, Bone, Surgical EMI
Gouge, Surgical, General & Plastic Surgery GDH
Forceps HTD
Specula, Ophthalmic HNC
Burr, Orthopedic HTT
Instruments, Dental Hand DZN
Trocar, Gastro-Urology FBQ
Clamp, Uterine HGC
Scissors, Surgical Tissue, Dental EGN
Applier, Cerclage HXN
Tap, Bone HWX
Plier, Orthodontic JEX
Accessories, Catheter KGZ
Intervertebral Fusion Device With Integrated Fixation, Lumbar OVD
Carrier, Amalgam, Operative EKI
Cannula, Manipulator/Injector, Uterine LKF
Spectacle, Magnifying HOI
Applicator, Absorbent Tipped, Non-Sterile KXF
Bougie, Urological FAX
Retractor, Ent KAL
Perforator, Antrum KAT
Stripper, Vein, Disposable GAJ
Depressor, Tongue, Non-Surgical FMA
Dilator, Esophageal (Metal Olive) Gastro-Urology EZM
Percussor GWZ
Device, Medical Examination, Ac Powered KZF
Light, Surgical, Floor Standing FSS
Forceps, Dressing, Dental EFL
Osteotome, Manual GFI
Instrument, Bending Or Contouring HXP
Handle, Instrument, Dental EJB
Elevator HTE
Cutter, Wire HXZ
Adaptor, Bulbs, Miscellaneous, For Endoscope FFY
Hook, Tracheal KCH
Forceps, Rongeur, Surgical EMH
Dissector, Surgical, General & Plastic Surgery GDI
Applicator, Absorbent Tipped, Sterile KXG
Instrument, Filling, Plastic, Dental EIY
Gauge, Measuring JYJ
Tubing, Noninvasive GAZ
Dilator, Lachrymal HNW
Retractor, Ophthalmic HNI
Instrument, Ligature Passing And Knot Tying HCF
Rasp, Nasal KBA
Clip, Removable (Skin) FZQ
Stethoscope, Manual LDE
Marker, Periodontic EMP
Curette, Surgical, General Use FZS
Irrigator, Sinus KAR
Pelvimeter, External HER
Carrier, Ligature GEJ
Hemostat, Surgical EMD
Holder, Camera, Surgical FXR
Coagulator-Cutter, Endoscopic, Unipolar (And Accessories) KNF
Fork HXE
Scissors, Episiotomy HDK
Plate, Bone JEY
Bit, Drill HTW
Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented OQI
Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented OQG
Hip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented OQH
Saw, Powered, And Accessories HAB
Blade, Scalpel GES
Punch, Surgical LRY
Mirror, General & Plastic Surgery FTX
Stripper, Vein, Reusable GAI
Evacuator, Bladder, Manually Operated FFD
Snare, Tonsil KBZ
Instrument, Manual, Surgical, General Use MDM
Hemostat HRQ
Elevator, Ent KAD
Snare, Nasal KBE
Plugger, Root Canal, Endodontic EKR
Rongeur, Powered HAD
Knife, Laryngeal JZY
Orthopedic Manual Surgical Instrument LXH
Tape, Measuring, Rulers And Calipers FTY
Reamer, Pulp Canal, Endodontic EKP
Dynamometer, Nonpowered HRW
Blade, Saw, General & Plastic Surgery, Surgical GFA
Countersink HWW
System, Digital Image Communications, Radiological LMD
Forceps, Ent KAE
Scrapper, Skin Specimen LXK

Proprietary Names

SUTURING INSTRUMENT SET Aesculap PROSTHESIS TEMPLATE EAR SNARE INSTRUMENT SURGICAL GUIDE NASAL SCISSORS PENILE CLAMP VAGINAL RETRACTOR SURGICAL ELEVATOR ORTHODONTIC WIRE CLAMP TONSILLECTOME TONSIL SUTURING NEEDLE AMPUTATION KNIFE RECTAL SPECULUM PERIODONTIC SCALER ORTHOPEDIC SURGICAL SAW GAUZE TONSIL KNIFE OPHTHALMIC FORCEPS ORTHOPEDIC SCREWDRIVER ENDOFREEZE RETENTION SURGICAL LOOP SUTURE AESCULAP ENT APPLICATOR ADENOTOME SINUS TROCAR EAR EXCAVATOR ONE-PIECE SCALPEL SURGICAL CLAMP MIDDLE-EAR CHISEL ORTHOPEDIC TREPHINE TREPHINE ENT ESOPHAGEAL DILATOR MIASPAS TL ACCESSORIES AND MANUAL SAW MANUAL SAW AND ACCESSORIES ORTHOPEDIC MALLET SURGICAL SAW WIRE TWISTER ORTHOPEDIC WIRE TWISTER CERVICAL DILATOR FIXED SIZE UTERINE DILATORS-COMPLETE SETS UTERINE DILATORS-COMPLETE SET ENT PROBE UMBILICAL SCISSORS *V* DIAGNOSTIC SET (ENT) OTOSCOPE AURAL MAGNIFIER DIAGNOSTIC SET (OTOSCOPE) BINOCULAR LOUPE ENT TUNING FORK TUNING FORK FEMORAL NECK PUNCH aesculap BIOPSY FORCEPS SURGICAL KNIFE SURGICAL DENTAL ELEVATOR ORTHOPEDIC RONGEUR ORTHOPEDIC CURETTE PERIODONTIC PROBE MICROSURGICAL EAR PICK ORTHODONTIC WIRE SURGICAL CANNULA ORTHOPEDIC EXTRACTOR UTERINE PACKER MOUTH GAG TONSIL DISSECTOR ORTHOPEDIC SURGICAL STRIPPER ORTHOPEDIC KNIFE SINUS CANNULA SELF-RETAINING RETRACTOR SKULL PUNCH SURGICAL SPATULA ORTHOPEDIC REAMER ORTHOPEDIC BENDER NASAL PUNCH HEMOSTATIC CLIP APPLIER SUSI OPERATIVE EXCAVATOR DENTAL ADENOID CURETTE Craniofix Peek ORTHOPEDIC WIRE HOLDING FORCEPS UTERINE PROBE SURGICAL CAMERA CUTTING INSTRUMENT ORTHOPEDIC RASP ORTHOPEDIC SCISSORS ORTHOPEDIC PROBE ORTHOPEDIC DEPTH GAUGE EAR KNIFE ENT SPECULUM METAL TONGUE DEPRESSOR ENT ORTHOPEDIC BONE SCREW STARTER DRILL BRACE PERIODONTIC KNIFE EAR CURETTE TONSIL PUNCH BONE CHISEL TOOTH FORCEP SURGICAL RASP OPERATIVE PLIERS ORTHOPEDIC SURGICAL FILE Acculan ENT SYRINGE NASAL KNIFE NON-POWERED SURGICAL INSTRUMENT EUSTACHIA CATHETER ORTHOPEDIC SURGICAL PLIERS AFT SYSTEM TROCAR HANDPIECE DRILL UTERINE CURETTE SURGICAL HOOK ORTHOPEDIC WIRE TAMP FILE SAW PASSER OSTEOTOME MALLEUS NIPPER OPTHALMIC CALIPER ANTRUM PUNCH ENT MIRROR CORKSCREW ORTHOPEDIC CORKSCREW MYRINGOTOMY KNIFE NASAL SAW WIRE CUTTING SCISSORS ENT INFUSOR FOR I.V. BAGS (MULTIPLE BRANDS) PRESSURE PNEUMATIC SAW REUSABLE ASPIRATION SURGICAL INSTRUMENT TRAY CONTAINER SYSTEM STERILE DISPENSER SET CLIP REMOVAL INSTRUMENT SURGICAL CURETTE RUBBER DAM CLAMP FORCEPS EAR SPECULUM HOLDER ORTHOPEDIC CLAMP ORTHOPEDIC WRENCH COMPRESSION INSTRUMENT POWDER BLOWER BONE FILE ORTHOPEDIC FORCEPS OPHTHALMIC SPECULA ORTHOPEDIC BURR Dental UTERINE CLAMP CERCLAGE INSTRUMENT BONE TAP BONE SCREW TAP ORTHODONTIC PLIER COTTON APPLICATORS COTTON APPLICATOR SURGICAL CLIP APPLIER UROLOGICAL BOUGIE ENT RETRACTOR ANTRUM PERFORATOR VEIN STRIPPER DENTAL DRESSING FORCEPS PLATE BENDER DENTAL INSTRUMENT HANDLE ORTHOPEDIC WIRE CUTTER WIRE CUTTER TRACHEAL HOOK RONGEUR FORCEPS MINOP OPHTHALMIC RETRACTOR LIGATURE PASSING LIGATURE PASSING AND KNOT TYING INSTRUMENT *V* NASAL RASP PERIODONTIC MARKER SINUS IRRIGATOR PELVIMETER LIGATURE CARRIER FORK ORTHOPEDIC FORK EPISIOTOMY SCISSORS ORTHOPEDIC DRILL REUSABLE VEIN STRIPPER TONSIL SNARE ENT ELEVATOR NASAL SNARE LARYNGEAL KNIFE MEASURING DEVICES SURGICAL SAW BLADE MULIPLE ORTHOPEDIC COUNTERSINK ENT FORCEPS

Establishment Types

Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device for Another Party (Contract Manufacturer) Export Device to the United States But Perform No Other Operation on Device Repack or Relabel Medical Device Develop Specifications But Do Not Manufacture At This Facility