FDA Registration
Active
🇺🇸 United States
Tray, Surgical Instrument
Reg #: 1526534
·
FEI: 1526534
·
Expires 2025
Products
1
Proprietary Names
218
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Sterigenics US, LLC
- Registration Number
- 1526534
- FEI Number
- 1526534
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 305 Enterprise Dr
- City
- Lewis Center
- State
- OH
- ZIP
- 43035
- Country
- US
Owner / Operator
- Firm Name
- Sotera Health LLC
- Operator Number
- 10029425
- Address
- 2015 Spring Road, Suite 650
- City
- Oak Brook
- State
- IL
- Postal Code
- 60523
- Country
- US
- Correspondent
- Karen Whaley-Krumins
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 2012-11-15 |
Proprietary Names
Tray, Surgical Instrument
PROXIMAL FEMUR IMPLANT TRAY LID
STER CASE-RINGS 80-130MM
PERI-LOC VLP DIST TIB/FIB LOCK PL TRAY
SMALL CANN SCREW INSTRUMENT TRAY
Single Use Magnetic Transfer Zone w/Tray 16" x 20"
CADDY {} MINI DRILLS
VLP FOOT COMPACT TRAY LID
PERI-LOC SHLDR LCK PL TRY
WIRE CAP LID
LG - UNI EXT FIX SYS OUT TRAY - SH TRAY
CADDY {} LG SCREWS
WIRE CAP TRAY
PROXIMAL FEMUR TARGETER INSTRUMENT TRAY
3 HEADLESS/2 QFX SCREW CADDY DROP-IN
SMALL CANN SCREW INSTRUMENT TRAY LID
RING CASE 130MM AND 205MM
STERIL TRAY F/SPAT FRAME STRUTS/WREN
PERI-LOC 4.5 S-T COR SC CDY LD
LG FRAG PLATE TRAY {} PF
VLP 2.7MM/3.5MM ANCILLARY INST TRAY
3.5MM L-P TIB LK PLT TRAY
EUROPEAN PROX FEM INSTR TRAY LID
WIRE CADDY LID
LONG CANN. SCREW CADDY LID
PERI-LOCK 5.7 CANN LCK SCR CDY
VLP 3.5MM/5MM IMPLANT TRAY
STER CASE-PLATES
EUROPEAN PROX FEM INSTR TRAY
JETX CENTRAL TR INSTR CASE
PERI-LOC 4.5 S-T LK SCR CDY LD
AUXILLARY INSTRU MODULE STER CASE W-LID
PERI-LOC VDR SCRW CADDY LID
CADDY {} SM INSTS {} DELUXE
PERI-LOC 2.7MM LCK SCREW CADDY
SMALL CANN SCREW INSTRUMENT INNER TRAY
RING CASE 155MM AND 180MM
JETX MINI TRAY
INSTRUMENT CASE LID
PERI-LOC VLP SCREW CADDY
PERI-LOC VLP AUXILIARY SCREW CADDY LID
HALF PIN MODULE STER CASE WITH LID
PERILOC 3.5MM STRT PL CDY LID
CADDY {} SM PLATES {} DELUXE
TSF PIN/WIRE STER TRAY
4.5MM LP TIB TRGTR TRAY
CADDY F/TSF BOLTS {} WASHERS
CADDY {} SM SCREWS {} DELUXE
CABLE SADDLE/HOLE FILLER CADDY
PERI-LOC 2.7MM INST & SCR TRAY
VLP 2.7MM/4MM IMPLANT TRAY
CADDY {} SM INSTS {} BASIC
STERILIZATION CASE-RINGS {} 200MM-240MM
PERI-LOC SM FRG INST TRAY SPCR
PERI-LOC VLP INSTRUMENT TRAY
PERI-LOC CLAVICLE INST & IMPL TRAY LID
STER CASE-RODS {} POSTS
TRAY {} LG FORCEPS
PERI-LOC CLAVICLE INST & IMPL TRAY
CABLE SADDLE AND LHI CADDY LID
STER CASE-WIRES {} INST
PERI-LOC PERI-ART FORCEPS TRAY LID
7MM SCREW CADDY LID
VLP FOOT IMPLANT TRAY LID
4.5MM L-P TIB LK PLATES TRAY
PERI 5.7MM CAN LCK SCW CDY LD
VLP 2.7MM/3.5MM INSTRUMENT TRAY
6.5MM SCREW CADDY LID
PERI-LOC VLP DRILL CADDY
TRAY B {} PELVIC INSTS
STER CASE-NUTS {} BOLTS
Single Use Magnetic Transfer Zone 16" x 20"
Single Use Non-Magnetic Zone 16" x 10"
VLP FOOT 2.7MM/4MM IMPLANT TRAY LID
TRAY {} PELVIC INSTS
RING CASE 130MM AND 205MM LID
TRAY {} BLADE PLATES
SMALL CANN SCREW CADDY LID
Single Use Magnetic Transfer Zone 16" x 10" - Private Label Leonhard Lang ST-12
Single Use Magnetic Transfer Zone 3" x 4.5" - Private Label Cardinal Health 100-10B
PERI 4.5MM CRTX SCRW CADY LD
SMALL CANN SCREW SYSTEM TRAY
PERI-LOC SM FRG SCREW CDY LID
PERI-LOC VLP DIST TIB/FIB LK PL TRAY LID
PERI-LOC SM FRG INS TRAY REV 1
PERI-LOC LG FRG INS TRAY REV 1
REF TR ACET LINR TRAY INS
4.5MM L-D FMR TRGTR TRAY
FRAME STABILIZER CASE
VLP 2.7mm/3.5mm BASE INSTRUMENT TRAY LID
PERI-LOC SM FRAG BASIC INST TRAY
PERI-LOC 4.5 S-T LCK SCR CADDY
PERI-LOC 6.5MM SCREW/INSTRUMENT TRAY
TRAY {} LG INSTRUMENTS
TRAY A {} PELVIC RED INSTS
PERI-LOC SM FRG STR LK PLT LID
REF TRIAL ACET SHELL TRAY
CADDY {} SM DRILLS
TRAY C {} PELVIC INSTS
JETX HALF PIN INSERTION TRAY
STER CASE-TELESCOPIC RODS
VLP 2.7mm/3.5mm INST TRAY LID
PERI-LOC VLP SCREW CADDY LID
TSF RINGS STER.TRAY
PERI-LOC 2.7MM INSTR&SCREW TRY
PERI-LOC FORCEPS TRAY
CADDY {} MINI INSTRUMENT
CADDY {} SM PLATES {} BASIC
PERI-LOC 2.7MM DR GD CADDY
PROXIMAL FEMUR TARGETER OUTER TRAY LID
SPATIAL FRAME HARDWARE CASE
JET-X IMPLANT TRAY
PERI-LOC SM FRAG SCREW CADDY
4.5MM L-D FEMUR LK PL TRAY
JET-X CENTRAL TRAUMA IMPL CASE
PERI-LOC VLP IMPLANT TRAY
P-L 2.7MM DRL GD CDY LD
3.5MM L-P TIB TGR TRAY
JET-X 6MM HALF PIN INSERT TRAY
CADDY {} MINI SCREWS
LID INSERT F/TSF ASSEMBLY
PERI-LOC SM FRAG DRILL CADDY
AESCULAP BOTTOM CONT PERFORAT 90MM
LID {} CADDY {} MINI PLATES
VLP FOOT IMPLANT TRAY
PL 3.5 STR LCK/NOLCK PL CDY LD
SMALL CANN SCREW SYSTEM LID
3.5MM D TIB TGTR TRAY
PERILOC SM FRAG SCREW CDY LID
PERI-LOC VOL DST RAD SCRW CDDY
PERI-LOC CLAVICLE PL CADDY LID
AESCULAP LID W/RETENTION PLATE SILVER
8MM CANN SCREW CADDY
CADDY {} MINI PLATE
7MM CANN SCREW CADDY
Scalpel Holder
PERI-LOC SM FRG STR LCK PL CDY
3.5MM DSTL TIB CALC LK PL TRAY
PERI 6.5MM CANC SCW CDY LD
VLP 2.7MM/3.5MM BASE INSTRUMENT TRAY
STERILIZATION TRAY DRS
INSTRUMENT CASE
PERI-LOC 6.5MM SCREW/INSTRUMENT TRAY LID
OPTIONAL INSTRUMENT TRAY
2.5/3 CANN SCREW CADDY DROP-IN
Sharps Saf-T Zone w/o tray
Single Use Magnetic Transfer Zone w/ Tray 16" x 10"
Single Use Magnetic Transfer Zone 3" x 4 1/2"
PERI-LOC VOL DST RAD TRY LID
VLP FOOT TEMPLATE TRAY LID
PERI-LOC 6.5 CANC SCR CDY LID
LARGE - UNI EXT FIX SYS INNER TRAY LID
6.5MM CANN SCREW CADDY
HEX FIX COMPONENT TRAY
SMALL CANN SCREW CADDY
PERI-LOC 2.7MM SCREW CADDY LID
PROXIMAL FEMUR IMPLANT TRAY
RING CASE 155MM AND 180MM LID
Single Use Magnetic Transfer Zone 16" x 10" - Private Label NOVAPLUS 200-16B-V
PERI-LOC VLP INSTRUMENT TRAY LID
VLP FOOT COMPACT TRAY
CHISEL BLADE RADIAL 13X120X1MM - 18S
PERI-LOC 5.7 CAN SCREW CDY LID
PERI-LOC 6.5 CANC SCREW CADDY
AESCULAP BOTTOM CONT PERFORAT 135MM
PERI-LOC LG FRAG SCREW CADDY
SM FRAG PLATE CADDY {} CP/PF
TRAY {} PELVIC IMPLANTS
PERI-LOC VLP PROX TIB LOCK PL TRAY LID
PERI-LOC ELBOW LCK PL TRY
HEX FIX HALF PIN TRAY
FULL TRAY FOR LRG CANN SCRW
CADDY {} SM SCREWS {} BASIC
PERI-LOC VLP IMPLANT TRAY LID
LID {} CADDY {} MINI SCREWS
PERI-LOC SM FRAG STR PL CADDY
MAYO STAND CADDY
LG FRAG PLATE TRAY {} CP/PF
TRAY LID FOR LRG CANN SCREW
LONG CANNULATED SCREW CADDY
PERI-LOC SM FRAG BASIC INST TRAY LID
VLP FOOT 3.5MM/5MM IMPLANT TRAY LID
Single Use Magnetic Transfer Zone 16" x 10" - Private Label Cardinal Health 200-16B
PERI-LOC VOL DIST RAD TRY
LARGE FRAGMENT STRT PLT TRAY
HARDWARE CASE LID
LG - UNI EX FIX SYS OUT TRAY - TALL TRAY
PERI-LOC SM FRAG DRL GDE CADDY
LID {} CADDY {} SM SCREWS
LRG CANN SCR INSTR TRAY
PERI-LOC VLP PROX TIB LOCK PL TRAY
Single Use Magnetic Transfer Zone 16" x 10"
Sharps Saf-T Transfer Drape Non-Magnetic 32/case
PERI-LOC PERI-ART FORCEPS TRAY
WIRE CADDY
8MM SCREW CADDY LID
PERI-LOC VLP AUXILIARY SCREW CADDY
PERI-LOC 4.5MM LCK SCRW CDY LD
PERI-LOC 4.5 S-T CRTX SCR CDY
JETX 5MM XSHT HP INSRTN TRAY
TRAY {} LG PLATES
STER CASE-RINGS {} 140-180MM
VLP FOOT TEMPLATE TRAY
VLP 2.7mm/3.5mm ANCILLARY INST TRAY LID
PROXIMAL FEMUR TARGETER OUTER TRAY
PERI-LOC LG FRAG SCREW TRAY
LID CADDY {} SM PLATES {} DELUXE
LRG CANN SCR INSTR TRAY LID
PERI-LOC CLAVICLE PLATE CADDY
PERI-LOC SM FRAG INST TRAY
Single Use Magnetic Transfer Zone 16" x 20" -Private Label Cardinal Health 200-20B
PIN, BLUNT, 2.4MM
NEEDLE COUNTER
80720- Single Use Magnetic Transfer Zone 16" x 20"
80710- Single Use Magnetic Transfer Zone 16" x 10"
80710CARD- Single Use Magnetic Transfer Zone 16" x 10" - Private Label Cardinal Health 200-16B
80730CARD- Single Use Magnetic Transfer Zone 3" x 4.5" - Private Label Cardinal Health 100-10B
80720CARD- Single Use Magnetic Transfer Zone 16" x 20" -Private Label Cardinal Health 200-20B
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)