71926734

GUDID 03596010483577

RETAINING RING REPLACEMENT

Smith & Nephew, Inc.

Constrained polyethylene acetabular liner Constrained polyethylene acetabular liner Constrained polyethylene acetabular liner Constrained polyethylene acetabular liner Constrained polyethylene acetabular liner Constrained polyethylene acetabular liner Constrained polyethylene acetabular liner Constrained polyethylene acetabular liner Constrained polyethylene acetabular liner Constrained polyethylene acetabular liner Constrained polyethylene acetabular liner Constrained polyethylene acetabular liner Constrained polyethylene acetabular liner 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 ID03596010483577
NIH Device Record Key6a9e63fb-7693-4df7-832b-98539ec66ecb
Commercial Distribution StatusIn Commercial Distribution
Version Model Number71926734
Catalog Number71926734
Company DUNS045483575
Company NameSmith & Nephew, Inc.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
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 Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM

Device Identifiers

Device Issuing AgencyDevice ID
GS103596010483577 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HSBROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[03596010483577]

Moist Heat or Steam Sterilization


[03596010483577]

Moist Heat or Steam Sterilization


[03596010483577]

Moist Heat or Steam Sterilization


[03596010483577]

Moist Heat or Steam Sterilization


[03596010483577]

Moist Heat or Steam Sterilization


[03596010483577]

Moist Heat or Steam Sterilization


[03596010483577]

Moist Heat or Steam Sterilization


[03596010483577]

Moist Heat or Steam Sterilization


[03596010483577]

Moist Heat or Steam Sterilization


[03596010483577]

Moist Heat or Steam Sterilization


[03596010483577]

Moist Heat or Steam Sterilization


[03596010483577]

Moist Heat or Steam Sterilization


[03596010483577]

Moist Heat or Steam Sterilization


[03596010483577]

Moist Heat or Steam Sterilization


[03596010483577]

Moist Heat or Steam Sterilization


[03596010483577]

Moist Heat or Steam Sterilization


[03596010483577]

Moist Heat or Steam Sterilization


[03596010483577]

Moist Heat or Steam Sterilization


[03596010483577]

Moist Heat or Steam Sterilization


[03596010483577]

Moist Heat or Steam Sterilization


[03596010483577]

Moist Heat or Steam Sterilization


[03596010483577]

Moist Heat or Steam Sterilization


[03596010483577]

Moist Heat or Steam Sterilization


[03596010483577]

Moist Heat or Steam Sterilization


[03596010483577]

Moist Heat or Steam Sterilization


[03596010483577]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2023-09-07
Device Publish Date2015-08-29

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00885556918043 - Trigen2024-04-18 8.5MM END CUTTING REAMER HEAD
00885556918050 - Polar2024-04-18 POLAR CALCAR PLANER - 40MM
00885556918067 - Polar2024-04-18 POLAR CALCAR PLANER - 45MM
00885556918029 - Trigen2024-04-16 DRILL SLEEVE DEPTH GAUGE
00885556917978 - Legion2024-04-10 EM PROXIMAL GUIDE - L

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