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
Tray, Surgical, Instrument FSM

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)