71930654

GUDID 00885556052488

FEMORAL TRIAL HANDLE

Smith & Nephew, Inc.

Surgical instrument handle, non-torque-limiting
Primary Device ID00885556052488
NIH Device Record Keyaa07b397-c9cb-49e4-b9b1-958a51cc3a02
Commercial Distribution Discontinuation2016-10-19
Commercial Distribution StatusNot in Commercial Distribution
Version Model Number71930654
Catalog Number71930654
Company DUNS109903521
Company NameSmith & Nephew, Inc.
Device Count1
DM Exemptfalse
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100885556052488 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HRYPROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00885556052488]

Moist Heat or Steam Sterilization


[00885556052488]

Moist Heat or Steam Sterilization


[00885556052488]

Moist Heat or Steam Sterilization


[00885556052488]

Moist Heat or Steam Sterilization


[00885556052488]

Moist Heat or Steam Sterilization


[00885556052488]

Moist Heat or Steam Sterilization


[00885556052488]

Moist Heat or Steam Sterilization


[00885556052488]

Moist Heat or Steam Sterilization


[00885556052488]

Moist Heat or Steam Sterilization


[00885556052488]

Moist Heat or Steam Sterilization


[00885556052488]

Moist Heat or Steam Sterilization


[00885556052488]

Moist Heat or Steam Sterilization


[00885556052488]

Moist Heat or Steam Sterilization


[00885556052488]

Moist Heat or Steam Sterilization


[00885556052488]

Moist Heat or Steam Sterilization


[00885556052488]

Moist Heat or Steam Sterilization


[00885556052488]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-08-09
Device Publish Date2015-09-28

Devices Manufactured by Smith & Nephew, Inc.

00885556768471 - EVOS2025-11-20 COLLINEAR CLAMP
00885556796559 - EVOS2025-11-20 COLLINEAR CLAMP REDUCTION AID - SPIKE WASHER DIAMETER 25MM
00885556796573 - EVOS2025-11-20 COLLINEAR CLAMP REDUCTION AID - SPIKE WASHER DIAMETER 15MM
00885556907467 - EVOS2025-11-20 EVOS PELVIC 3.5MM POSTERIOR WALL TABBED PLATE STANDARD 7 HOLE, LEFT
00885556907474 - EVOS2025-11-20 EVOS PELVIC 3.5MM POSTERIOR WALL TABBED PLATE STANDARD 8 HOLE, RIGHT
00885556911181 - EVOS2025-11-20 EVOS PELVIC BALL SPIKE STRAIGHT, SHORT
00885556911198 - EVOS2025-11-20 EVOS PELVIC BALL CROWN STRAIGHT, LONG
00885556911372 - EVOS2025-11-20 EVOS PELVIC BALL CROWN 30 DEGREE, ANGLED

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.