S-ROM NOILES 634325

GUDID 10603295181873

S-ROM NOILES PATELLAR RESTRAINING INSTRUMENT

DEPUY ORTHOPAEDICS, INC.

Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable
Primary Device ID10603295181873
NIH Device Record Key0ea6b473-4d9f-466b-815f-0db0e7361ff6
Commercial Distribution StatusIn Commercial Distribution
Brand NameS-ROM NOILES
Version Model Number63-4325
Catalog Number634325
Company DUNS080506581
Company NameDEPUY ORTHOPAEDICS, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx

Device Identifiers

Device Issuing AgencyDevice ID
GS110603295181873 [Primary]

FDA Product Code

LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[10603295181873]

Moist Heat or Steam Sterilization


[10603295181873]

Moist Heat or Steam Sterilization


[10603295181873]

Moist Heat or Steam Sterilization


[10603295181873]

Moist Heat or Steam Sterilization


[10603295181873]

Moist Heat or Steam Sterilization


[10603295181873]

Moist Heat or Steam Sterilization


[10603295181873]

Moist Heat or Steam Sterilization


[10603295181873]

Moist Heat or Steam Sterilization


[10603295181873]

Moist Heat or Steam Sterilization


[10603295181873]

Moist Heat or Steam Sterilization


[10603295181873]

Moist Heat or Steam Sterilization


[10603295181873]

Moist Heat or Steam Sterilization


[10603295181873]

Moist Heat or Steam Sterilization


[10603295181873]

Moist Heat or Steam Sterilization


[10603295181873]

Moist Heat or Steam Sterilization


[10603295181873]

Moist Heat or Steam Sterilization


[10603295181873]

Moist Heat or Steam Sterilization


[10603295181873]

Moist Heat or Steam Sterilization


[10603295181873]

Moist Heat or Steam Sterilization


[10603295181873]

Moist Heat or Steam Sterilization


[10603295181873]

Moist Heat or Steam Sterilization


[10603295181873]

Moist Heat or Steam Sterilization


[10603295181873]

Moist Heat or Steam Sterilization


[10603295181873]

Moist Heat or Steam Sterilization


[10603295181873]

Moist Heat or Steam Sterilization


[10603295181873]

Moist Heat or Steam Sterilization


[10603295181873]

Moist Heat or Steam Sterilization


[10603295181873]

Moist Heat or Steam Sterilization


[10603295181873]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2022-05-13
Device Publish Date2018-09-24

On-Brand Devices [S-ROM NOILES]

10603295181880S-ROM NOILES PATELLAR CEMENT CLAMP
10603295180722S-ROM NOILES AUGMENT BLOCK CEMENT CLAMP
10603295179856S-ROM NOILES ROTATING HINGE MODULAR TIBIAL STEM EXTENSION WITH SCREW 21mm x 100mm
10603295179849S-ROM NOILES ROTATING HINGE MODULAR TIBIAL STEM EXTENSION WITH SCREW 19mm x 100mm
10603295179832S-ROM NOILES ROTATING HINGE MODULAR TIBIAL STEM EXTENSION WITH SCREW 17mm x 100mm
10603295179825S-ROM NOILES ROTATING HINGE MODULAR TIBIAL STEM EXTENSION WITH SCREW 15mm x 150mm
10603295179818S-ROM NOILES ROTATING HINGE MODULAR TIBIAL STEM EXTENSION WITH SCREW 15mm x 100mm
10603295179801S-ROM NOILES ROTATING HINGE MODULAR TIBIAL STEM EXTENSION WITH SCREW 13mm x 150mm
10603295179795S-ROM NOILES ROTATING HINGE MODULAR TIBIAL STEM EXTENSION WITH SCREW 13mm x 100mm
10603295179788S-ROM NOILES ROTATING HINGE MODULAR TIBIAL STEM EXTENSION WITH SCREW 11mm x 150mm
10603295179771S-ROM NOILES ROTATING HINGE MODULAR TIBIAL STEM EXTENSION WITH SCREW 11mm x 100mm
10603295179764S-ROM NOILES ROTATING HINGE MODULAR TIBIAL STEM EXTENSION WITH SCREW 9mm x 150mm
10603295179757S-ROM NOILES ROTATING HINGE MODULAR TIBIAL STEM EXTENSION WITH SCREW 9mm x 100mm
10603295181798S-ROM NOILES PATELLAR REAMER 32mm
10603295181781S-ROM NOILES PATELLAR REAMER 35mm
10603295181774S-ROM NOILES PATELLAR REAMER 38mm
10603295181767S-ROM NOILES PATELLAR REAMER 30mm
10603295178286S-ROM NOILES PATELLAR INSTRUMENTS - CASE Number 7
10603295093756S-ROM NOILES HINGE FEMORAL PREP TRAY
10603295093732S-ROM NOILES HINGE FEMORAL PREP BASE
10603295093725S-ROM NOILES HINGE FEMORAL PREP LID
10603295093718S-ROM NOILES HINGE FEMORAL PREP SET
10603295179092S-ROM NOILES PATELLA DOME 38mm X 10mm
10603295179085S-ROM NOILES PATELLA DOME 35mm X 9mm
10603295179078S-ROM NOILES PATELLA DOME 32mm X 8.5mm
10603295179061S-ROM NOILES PATELLA DOME 30mm X 8mm
10603295181606S-ROM NOILES ROTATING HINGE FEMORAL TRIAL X-SMALL RIGHT
10603295181590S-ROM NOILES ROTATING HINGE FEMORAL TRIAL X-SMALL LEFT
10603295181583S-ROM NOILES ROTATING HINGE BOX TRIAL
10603295181576S-ROM NOILES ROTATING HINGE FEMORAL TRIAL SMALL RIGHT
10603295181569S-ROM NOILES ROTATING HINGE FEMORAL TRIAL SMALL LEFT
10603295181521S-ROM NOILES HINGE PIN TRIAL
10603295181514S-ROM NOILES ROTATING HINGE FEMORAL TRIAL MEDIUM LEFT
10603295181507S-ROM NOILES ROTATING HINGE FEMORAL TRIAL MEDIUM RIGHT
10603295180845S-ROM NOILES POSTERIOR STABILIZED FEM AUGMENT TRIAL-COMBO 10/10mm MED/LG/XLG
10603295180838S-ROM NOILES PS FEMORAL AUGMENT TRIAL - COMBO 10/5mm MED/LG/XLG
10603295180821S-ROM NOILES POSTERIOR STABILIZED FEM AUGMENT TRIAL-COMBO 5/5mm MED/LG/XLG
10603295180814S-ROM NOILES POSTERIOR STABILIZED FEM AUGMENT TRIAL-POSTERIOR 10mm MED/LG/XLG
10603295180791S-ROM NOILES POSTERIOR STABILIZED FEM AUGMENT TRIAL-DISTAL 10mm MED/LG/XLG
10603295180784S-ROM NOILES POSTERIOR STABILIZED FEM AUGMENT TRIAL-DISTAL 5mm MED/LG/XLG
10603295180654S-ROM NOILES ROTATING HINGE FEMORAL AUGMENT TRIAL - DISTAL 10mm
10603295180647S-ROM NOILES ROTATING HINGE FEMORAL AUGMENT TRIAL - DISTAL 5mm
10603295181873S-ROM NOILES PATELLAR RESTRAINING INSTRUMENT
10603295180043S-ROM NOILES BONE DRILL - LONG 3.2mm
10603295181835S-ROM NOILES PATELLAR REAMER DEPTH ADJUSTER 38mm
10603295181828S-ROM NOILES PATELLAR REAMER DEPTH ADJUSTER 35mm
10603295181811S-ROM NOILES PATELLAR REAMER DEPTH ADJUSTER 32mm
10603295181804S-ROM NOILES PATELLAR REAMER DEPTH ADJUSTER 30mm
10603295180692S-ROM NOILES IMPACTION CAP
10603295180661S-ROM NOILES TIBIAL TRAY DRIVER

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