FDA Registration Active 🇺🇸 United States

STERIS ISOMEDIX PUERTO RICO, INC.

Reg #: 2648623 · FEI: 2648623 · Expires 2026
Products
64
Proprietary Names
236
Establishment Types
1
Classifications
64

Registration Details

Registration Name
STERIS ISOMEDIX PUERTO RICO, INC.
Registration Number
2648623
FEI Number
2648623
Status
Active
Expiry Year
2026
Initial Importer
No
Address
KM 1 7, STATE Road, 690, BARRIO SABANA HOYOS
City
Alts De Cerro Gordo 3&4
State
PR
ZIP
00692
Country
US

Owner / Operator

Firm Name
STERIS Corporation
Operator Number
1527821
Address
5960 Heisley Rd, --
City
Mentor
State
OH
Postal Code
44060
Country
US

Products

Device Name Product Code
Arthroscope HRX
Cement, Bone, Vertebroplasty NDN
Thoracolumbosacral Pedicle Screw System NKB
Appliance, Fixation, Spinal Interlaminal KWP
Appliance, Fixation, Spinal Intervertebral Body KWQ
Intervertebral Fusion Device With Bone Graft, Cervical ODP
Instrument, Biopsy KNW
Staple, Implantable GDW
Intervertebral Fusion Device With Bone Graft, Lumbar MAX
Fastener, Fixation, Nondegradable, Soft Tissue MBI
Spinal Vertebral Body Replacement Device MQP
Orthosis, Spinal Pedicle Fixation MNI
Orthosis, Spondylolisthesis Spinal Fixation MNH
Blade, Saw, General & Plastic Surgery, Surgical GFA
Gauze/Sponge, Internal, X-Ray Detectable GDY
Cement Obturator LZN
Container, I.V. KPE
Motor, Drill, Pneumatic HBB
Apparatus, Suction, Operating-Room, Wall Vacuum Powered GCX
Laparoscope, Gynecologic (And Accessories) HET
Evacuator, Gastro-Urology KQT
Screw, Fixation, Bone HWC
Instrument, Surgical, Disposable KDC
Container, Empty, For Collection & Processing Of Blood & Blood Components KSR
Accessories, Arthroscopic NBH
Electrosurgical, Cutting & Coagulation & Accessories GEI
Catheter, Electrode Recording, Or Probe, Electrode Recording DRF
Bone Cement LOD
Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile GAQ
Bit, Drill HTW
Pin, Fixation, Threaded JDW
Drills, Burrs, Trephines & Accessories (Simple, Powered) HBE
Orthopedic Stereotaxic Instrument OLO
System, Irrigation, Urological LJH
Lavage, Jet FQH
Electrode, Pacemaker, Temporary LDF
Intervertebral Fusion Device With Integrated Fixation, Lumbar OVD
Bur, Ear, Nose And Throat EQJ
Scalpel, One-Piece GDX
Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis OSH
Suture, Nonabsorbable, Synthetic, Polyethylene GAT
Suture, Nonabsorbable, Synthetic, Polyamide GAR
Suture, Nonabsorbable, Synthetic, Polypropylene GAW
Suture, Absorbable, Natural GAL
Suture, Absorbable, Synthetic, Polyglycolic Acid GAM
Suture, Nonabsorbable, Silk GAP
Agent, Absorbable Hemostatic, Non-Collagen Based LMG
Tube, Aspirating, Flexible, Connecting BYY
Mixer, Cement, For Clinical Use JDZ
Spinal Channeling Instrument, Vertebroplasty OCJ
Posterior Cervical Screw System NKG
Intervertebral Fusion Device With Integrated Fixation, Cervical OVE
Needle, Cerclage, Gynecological HDH
Barrier, Absorbable, Adhesion MCN
Heart-Valve, Mechanical LWQ
Kit, Surgical Instrument, Disposable KDD
Retractor GAD
Blade, Scalpel GES
Orthopedic Manual Surgical Instrument LXH
Injector, Vertebroplasty (Does Not Contain Cement) OAR
Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece ERL
Clamp, Vascular DXC
Cardiac Ablation Percutaneous Catheter LPB
Bone Cement, Posterior Screw Augmentation PML

Proprietary Names

StrykerPR3324 (VG) - Balloon Catheters 8G 15MM, 8G 20MM, 10G 10MM, 10G 15MM, 10G 20MM, 11G 10MM, 11G 15MM StrykerPR3324 (GR, LS, VG) - 10 G Bone Biopsy kit StrykerPR3324 (GR, LS, VG) - iVAS Bone Biopsy Kit 10G, 11G, 13G StrykerPR3324 (GR) - 10 G Bone Biopsy kit StrykerPR3324 (GR,VG) - 8 Gauge Biopsy StrykerPR3324 (GR,VG) - 13G Bone Biopsy Kit StrykerPR3324 (GR,VG) - 9" 10G Bone Biopsy Kit StrykerPR3324 (GR, LS, VG) - 11G Bone Biopsy Kit StrykerPR3324 (GR,VG) - 10G Biopsy Kit BardPR3770 (VG) - OptiFix Absorbable Fixation System StrykerPR3324 (GR, VG) - Omega PEEK Knotless Anchor System StrykerPR3324 (GR, VG) - OMEGA 4.75MM PEEK KNOTLESS ANCHOR SYSTEM, SINGLE OmegaSurgical (LSRTC) - BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL Zimmer (LN) - blade, saw, general and plastic surgery, surgical StrykerPR3324 (GR, LS, VG) - PKG ,ENT IRR.AGG.SHAVER BLADE StrykerPR3324 (GR, LS, VG) - SJ Cutter Mnscs StrykerPR3324 (GR, LS, VG) - Cutter Meniscus StrykerPR3324 (GR) - 4 mm ENT MicroDebrider AGGRESSIVE SERRATED StrykerPR3324 (GR, LS, VG) - Cutter Full Radius StrykerPR3324 (GR, LS, VG) - Bur TMJ 2mm StrykerPR3324 (GR, LS, VG) - Bur TMJ 3mm StrykerPR3324 (GR, LS, VG) - SJ Cutter StrykerPR3324 (GR, LS) - 4mm Aggressive Serrated StrykerPR3324 (GR, LS, VG) - SHARPEDGE SHAVER BLADE 4MM StrykerPR3324 (VG) - Full Radius Cutter, Arthroscopic Shaver Blade StrykerPR3324 (VG) - Hooded Abrasion Bur, Arthroscopic Shaver Blade StrykerPR3324 (VG) - Aggressive Cutter, Arthroscopic Shaver Blade OrchidUnique5936 (LN) - Blade, Saw, General & Plastic Surgery, Surgical - Signature Series UltraLite StrykerPR3324 (VG) - ACM system with cancellous StrykerPR3324 (VG) - iVAS Bone Biopsy Kit 8G StrykerPR3324 (GR, LS, VG) - STRYKER AHTO TUBE SET PACKAGING Stryker3324 (GR, LS, VG) - STRYKER AHTO DUAL SPIKE TUBE SET PACKAGING StrykerPR3324 (GR, LS, VG) - STRYKER AHTO TUBE SET WITH TIP PACKAGING StrykerPR3324 (GR, LS, VG) - Ahto Cassette Tube Set StrykerPR3324 (GR, LS, VG) - Ahto Cassette Tube Set with tip StrykerPR3324 (GR, LS, VG) - Ahto Cassette Tube Set With Y Connector StrykerPR3324 (GR, LS, VG) - Ahto Dual Spike Cassette Tube Set StrykerPR3324 (GR,VG,LN) - Bioprep Cement Restrictor KeySurgical6941 (LS) - Vascular Loops Syntech7829 (NT) - The Ahn Tray/ Ahn Tray StrykerPR3324 (GR, LS) - 8 X 75mm Dri-Lok Cannula Threaded StrykerPR3324 (GR, LS) - 6.5mm X 75mm Distal Threaded Cannula StrykerPR3324 (GR, LS) - 6.5mm X 90mm Threaded Cannula StrykerPR3324 (GR, LS, VG) - CANNULA PLUG StrykerPR3324 (GR, LS) - 5 X 75mm Dri-Lok Cannula Non-Threaded StrykerPR3324 (GR, LS) - 6.5mm X 90mm Distal Threaded Cannula StrykerPR3324 (GR, LS) - 8mm X 90mm Distal Threaded Cannula StrykerPR3324 (GR, LS) - 5mm X 90mm Distal Threaded Cannula StrykerPR3324 (GR, LS) - 6.5 X 75mm Dri-Lok Cannula Threaded StrykerPR3324 (GR, LS) - 8mm X 90mm Threaded Cannula StrykerPR3324 (GR, LS) - 5mm X 75mm Distal Threaded Cannula StrykerPR3324 (GR, LS) - 8 X 75mm Dri-Lok Cannula Non-Threaded StrykerPR3324 (GR, LS) - 5 X 75mm Dri-Lok Cannula Threaded StrykerPR3324 (GR, LS) - 8mm X 75mm Distal Threaded Cannula StrykerPR3324 (GR, LS) - 6.5 X 75mm Dri-Lok Cannula Non-Threaded StrykerPR3324 (GR, LS) - 5mm X 90mm Threaded Cannula Smith&Nephew3754 (NR) - CLEAR-TRAC Flexible Cannula, 5.5 x 45mm Threaded Smith&Nephew3754 (NR) - CLEAR-TRAC Disposable Scope/Shaver Cannula, with Distal Rib Smith&Nephew3754 (NR) - Fixation Post, 5mm x 30mm Smith&Nephew3754 (NR) - DISP KNIFE ROSSETTE 3MM STR(5) Smith&Nephew3754 (NR) - CLEAR-TRAC Flexible Cannula, 5.5 x 72mm Threaded Smith&Nephew3754 (NR) - Clear-Trac Complete Cannula System, 7mm x 72mm, Threaded Smith&Nephew3754 (NR) - SUTURE Threaders Smith&Nephew3754 (NR) - CLEAR-TRAC Flexible Cannula, 8 x 72mm Threaded Smith&Nephew3754 (NR) - Clear-Trac Complete Cannula System, 8.5mm x 45mm, Threaded Smith&Nephew3754 (NR) - ACUFEX Clear.Trac Threadedd.10 IDx76 LTX(10) Smith&Nephew3754 (NR) - DISPOSABLE KNIFE V SHAPED Smith&Nephew3754 (NR) - Fixation Post, 6.5mm x 35mm Smith&Nephew3754 (NR) - Clear-Trac Screw Cann 8mm LTX Free (10) Smith&Nephew3754 (NR) - CLEAR-TRAC Flexible Cannula, 6.5 x 72mm Threaded Smith&Nephew3754 (NR) - Clear-Trac Complete Cannula System, 8.5mm x 90mm, Threaded Smith&Nephew3754 (NR) - DISPOSABLE KNIFE HOOK 3MM (5) Smith&Nephew3754 (NR) - Split Cannula Smith&Nephew3754 (NR) - Clear-Trac Complete Cannula System, 4.5mm x 72mm, Threaded Smith&Nephew3754 (NR) - CLEAR-TRAC Disposable Scope/Shaver Cannula, Smooth Smith&Nephew3754 (NR) - TRANSPORTER (BOX 4) STERILE Smith&Nephew3754 (NR) - Clear-Trac Thrd Cann 5mm/76mm LTX Free (10) B Smith&Nephew3754 (NR) - Endoscopic Cann.Drill.Bit 4.5mm Smith&Nephew3754 (NR) - CLEAR-TRAC Flexible Cannula, 8 x 90mm Threaded Smith&Nephew3754 (NR) - Fixation Post, 5mm x 40mm Smith&Nephew3754 (NR) - CLEAR-TRAC Flexible Cannula, 6.5 x 72mm Smooth Smith&Nephew3754 (NR) - Clear-Trac Complete Cannula System, 7mm x 72mm, Smooth Smith&Nephew3754 (NR) - Univ Cannula 5mm/76mm LTX Free (10) Blue Smith&Nephew3754 (NR) - 3.8mm Tapered Awl, Disposable Smith&Nephew3754 (NR) - Clear-Trac Screw Cann 9mm LTX Free (10) Smith&Nephew3754 (NR) - DISPOSABLE KNIFE SERRATED (5) Smith&Nephew3754 (NR) - PCL Safety Guidewire, 2.4mm x 25cm Smith&Nephew3754 (NR) - Guide Wire, 1.2mm x 12” (Box 5) Smith&Nephew3754 (NR) - Guide Wire, 1.2mm x 9” (Box 5) Smith&Nephew3754 (NR) - CLEAR-TRAC Flexible Cannula, 4.5 x 72mm Threaded Smith&Nephew3754 (NR) - Fixation Post, 6.5mm x 30mm Smith&Nephew3754 (NR) - MENISCUS MENDER II DISPOSABLE Smith&Nephew3754 (NR) - Clear-Trac Complete Hip Cannula Smith&Nephew3754 (NR) - Clear-Trac Complete Cannula System, 5.5mm x 45mm, Threaded Smith&Nephew3754 (NR) - Clear-Trac Screw Cann 7mm LTX Free (10) Smith&Nephew3754 (NR) - CLEAR-TRAC Flexible Cannula, 5.5 x 55mm Threaded Smith&Nephew3754 (NR) - DISPOSABLE KNIFE SHARP TIP Smith&Nephew3754 (NR) - Flexible Passing Pin, 13.50” X 2.4mm (Qty 5) Smith&Nephew3754 (NR) - SUTURE PASSER 2 STERILE Smith&Nephew3754 (NR) - Passing Pin, Drill Tip, 2.4mm x 15” Smith&Nephew3754 (NR) - DISP KNIFE SERRATED FLAT(BX 5) Smith&Nephew3754 (NR) - Clear-Trac Threaded Cann 8mm/76mm LTX Free (10) G Smith&Nephew3754 (NR) - (6) Guidewire 2mm x 15 Smith&Nephew3754 (NR) - Univ Cannula 7mm/76mm LTX Free (10) Green Smith&Nephew3754 (NR) - (5) Guidewire, 1.2mmx 18” (46 cm) Smith&Nephew3754 (NR) - Fixation Post, 5mm x 35mm Smith&Nephew3754 (NR) - Fixation Post, 6.5mm x 25mm Smith&Nephew3754 (NR) - SUTURE PASSER 12 STERILE Smith&Nephew3754 (NR) BONE TUNNEL PLUG CANN 7-12MM LTX FREE (6 Smith&Nephew3754 (NR) - CLEAR-TRAC Flexible Cannula, 8 x 72mm Smooth Smith&Nephew3754 (NR) - Clear-Trac Complete Cannula System, 8.5mm x 72mm, Threaded Smith&Nephew3754 (NR) - Fixation Post, 5mm x 25mm Smith&Nephew3754 (NR) - Clear-Trac Complete Stopcock Valve Smith&Nephew3754 (NR) - Fixation Post, 6.5mm x 40mm Smith&Nephew3754 (NR) - DISP KNIFE ROUND TIP (BX 5) Smith&Nephew3754 (NR) - CLEAR-TRAC Flexible Cannula, 5.5 x 55mm Smooth Smith&Nephew3754 (NR) - Clear-Trac Complete Cannula System, 5.5mm x 72mm, Threaded Conmed (SX) - FENESTRATED CANNULA StrykerPR3324 (GR,LS, VG) - Strykeflow Single Spike Tube Set StrykerPR3324 (GR, LS, VG) - PKG., STRYKEFLOW SUCTION/IRRIGATOR PS StrykerPR3324 (VG,GR) - StrykeFlow PS StrykerPR3324 (VG,GR) - Strykeflow Single Spike Tube Set StrykerPR3324 (VG) - Autoplex Zimmer (LN,LS) - Bit, drill StrykerPR3324 (GR, LS, VG) - Twinloop FLEX TM Drill StrykerPR3324 (GR, LS, VG) - TwinLoop FLEX Zimmer (LN,LS) - Cannulated toggle button drill 4.5 MM Zimmer (LN,LS) - Maxfire Zimmer (LN,LS) - Toggleloc Eagle1350 (NT,SN) - Drill OmegaSurgical (LSRTC) - BIT, DRILL OrchidUnique5936 (LN) - Bit, Drill - Omega BardPR3770 (VG) - Sorbafix Absorbable Fixation System StrykerPR3324 (GR, VG) - AHTO SUCTION/IRRIGATION DUAL SPIKE TUBE SET StrykerPR3324 (GR, VG) - STRYKEFLOW2 WITH DISPOSABLE TIP (6BX) StrykerPR3324 (GR, VG) - PKG.SINUFLOW SUCTION/IRRIGATOR StrykerPR3324 (GR, VG) - AHTO SUCTION/IRRIGATION TUBE SET (6BX) StrykerPR3324 (GR, VG) - AHTO SUCTION/IRRIGATION TUBE SET WITH DISPOSABLE TIP (6BX) StrykerPR3324 (VG) - STRYKER TITANIUM CROSS SCREW SYSTEM StrykerPR3324 (GR, LS, VG) - PKG.40 DEG ANGLED CONVEX StrykerPR3324 (GR, LS, VG) - IRR JAGUAR CUTTER 3.5MM StrykerPR3324 (GR, LS, VG) - IRR JAGUAR CUTTER 4MM StrykerPR3324 (GR, LS, VG) - PKG.IRR.AGG.MENISCUS CUTTER StrykerPR3324 (VG) - 5MM X 75MM DRI-LOK CANNULA DISTAL THREAD StrykerPR3324 (VG) - 6.5MM X 90MM DRI-LOK THREADED CANNULA StrykerPR3324 (VG) - 8MM X 75MM DRI-LOK CANNULA DISTAL THREAD StrykerPR3324 (VG)- 6.5MM X 75MM DRI-LOK CANNULA DISTAL THREAD StrykerPR3324 (VG) - 8MM X 75MM NON-THREADED DRI-LOK CANNULA (5BX) StrykerPR3324 (VG) - 5MM X 75MM THREADED DRI-LOK CANNULA (5BX) StrykerPR3324 (VG) - 5MM X 75MM NON-THREADED DRI-LOK CANNULA (5BX) StrykerPR3324 (VG) - 6.5MM X 75MM THREADED StrykerPR3324 (VG) - 5MM X 90MM DRI-LOK CANNULA DISTAL THREAD StrykerPR3324 (VG) - 6.5MM X 90MM DRI-LOK CANNULA DISTAL THREAD StrykerPR3324 (VG) - 5MM X 90MM DRI-LOK THREADED CANNULA StrykerPR3324 (VG) - 8MM X 90MM DRI-LOK CANNULA DISTAL THREAD StrykerPR3324 (VG) - 8MM X 90MM DRI-LOK THREADED CANNULA StrykerPR3324 (VG) - 6.5MM X 75MM NON-THREADED DRI-LOK CANNULA (5BX) Ecomed7308 (LN) - Sureglide LSO2556 (NT) - C Safe StrykerPR3324 (LN,VG) - Universal ACL Instrumentation System MedtronicPR2690 (VG) - Marinr Steerable Intracardiac Electrode Catheter MedtronicPR2690 (VG) - StableMapr Steerable Intracardiac Electrode Catheter BardPR3770 (VG) - OptiFix Open Absorbable Fixation System BardPR3770 (VG) - OptiFix AT Absorbable Fixation System with Articulating Technology StrykerPR3324 (GR, LS, VG) - Krackow Press. StrykerPR3324 (VG) - iVAS Hand Drill Ranfac3098 (NR) - Access Needle, Ranfac Bone Access Needle, Ranfac Access Needle Kimball7603 (LN) - Curette 11G Ranfac3098 (NR) - Bone Access Needle Kimball7603 (LN) - Curette 10G StrykerPR3324 (VG) - CinchLock Flex MedtronicPR2690 (VG) - Torqr Intracardiac Electrode Catheter MedtronicPR2690 (VG) - Soloist Intracardiac Electrode Catheter StrykerInstruments (LS) - iVAS 8 GAUGE HAND DRILL StrykerInstruments (LS) - iVAS 8 Gauge Access Cannula StrykerInstruments (LS) - 10 Gauge Hand Drill Sterile StrykerInstruments (LS) - iVAS 8G Bevel Stylet StrykerPR3324 (GR, VG) - ACL DISPOSABLE PACK-SOFT TISSUE FIXATION StrykerPR3324 (GR, VG) - ACL DISPOSABLE PACK BONE-TENDON-BONE BVI1689 (EP1) - CustomEyes Acuderm1463 (WH,LS) -Acu-Punch Kit Spineology5627 (MN) - E Blades/Rakes Spineology5627 (MN) - SOAR Portal Tubes Protech3048 (TM) - Metaphyseal Kit, 5 Pack Spineology5627 (MN) - Retractor Protech3048 (TM) - Diaphyseal Kit, Single Spineology5627 (MN) - Duo Disposable Instruments Protech3048 (TM) - Universal Pin in Place Guide Protech3048 (TM) - Diaphyseal Kit, 5 Pack Merit1383 (SN,NT) - Futura Safety Scalpel BVI1689 (EP1) - Beaver Sclerotome Blade BVI1689 (EP1) - Beaver Mini-Blades BVI1689 (EP1) - Beaver Pocket Blade BVI1689 (EP1) - BeaverGuard Blade StrykerPR3324 (VG) - Verteport Manifold ItekMed5707 (LS) - ABC Cement Dispenser StrykerPR3324 (GR, VG) - StrykerFlow suction Irrigator StrykerPR3324 (GR, VG) - 2.5mm AGGRESSIVE BLADE 11cm StrykerPR3324 (GR, VG) - 4mm ANGLED AGGRESSIVE 60 DEG Stryker Puerto Rico - 4MM 40 DEG. AGG SERR BLADE StrykerPR3324 (GR, VG) - 3.5mm JAGUAR BLADE StrykerPR3324 (GR, VG) - 4MM 60 DEG. AGG SERR BLADE StrykerPR324 (GR, VG) - 3.5mm 40 Deg. Agg. Serrated StrykerPR 3324 (GR, VG) - 4mm AGGRESSIVE SERRATE StrykerPR3324 (GR, VG - 3.5mm 40 Degree Angled Aggressive Serrated Blade StrykerPR3324 (GR, VG) - 4mm 60 Degree Angle Aggressive Balde StrykerPR3324 (GR, VG) - 4mm JAGUAR BLADE StrykerPR3324 (GR, VG) - 3mm ROUND BUR StrykerPR3324 (GR, VG) - 4mm ANGLED AGGRESSIVE 40 DEG Stryker Puerto Rico - 4mm AGGRESSIVE BLADE StrykerPR3324 (GR, VG) - 4mm Angle Aggressive Blade StrykerPR3324 (GR, VG) - 3.5mm Jaguar Blade StrykerPR3324 (GR, VG) - 3.5mm 60 Degree Angled Aggressive Serrated Blade StrykerPR3324 (GR, VG) - 4mm Aggressive Blade StrykerPR3324 (GR, VG) - 4mm Aggressive Blade 11CM StrykerPR3324 (GR, VG) - 4mm SHARPEDGE BLADE Stryker3324 (GR) - 4mm Jaguar Blade StrykerPR3324 (GR, VG) - 3.5mm Aggressive Blade Stryker Puerto Rico - 2mm ROUND BUR StrykerPR3324 (GR) - 4MM 60 DEG. AGG SERR BLADE StrykerPR3324 (GR, VG) - 4MM 40 DEG. AGG SERR BLADE StrykerPR3324 (GR, VG) - 2.5mm Aggressive Blade Stryker3324 (GR) - 3mm Round Bur StrykerPR3324 (GR, LS) - 4mm Agle Aggressive Blade StrykerPR3324 (GR, VG) - 3.5mm Aggressive Serrated StrykerPR3324 (GR, VG) - 4mm Sharpedge Stryker3324 (GR) - 3.5mm 60 Degree Angle Aggressive Serrated Blade StrykerPR3324 (GR, VG) - iVAS Bone Biopsy Kit 10G, 11G, 13G Edwards11821 (VG) - VASCULAR CLAMP Edwards11821 (VG) - Fogarty Safejaw Spring Clip 6mm Edwards11821 (VG) - Fogarty Everclip 6mm Spring Clip Edwards11821 (VG) - Fogarty Softjaw - Fogarty Spring Clips 12mm Edwards11821 (VG) - Fogarty Safejaw - Fogarty Spring Clips 6mm Edwards11821 (VG) - Fogarty Softjaw - Fogarty Spring Clips 6mm StrykerPR3324 (VG) - 4mm AGGRESSIVE BLADE 11cm StrykerPR3324 (GR, LN, VG) - ACM; AEQUALIS PERFORM; AUTOPLEX; MIXER; MIXEVAC CEMENT MIXERS AND KITS; PCD; REVOLUTION

Establishment Types

Sterilize Medical Device for Another Party (Contract Sterilizer)