R2 E0015228-13

GUDID 00885556663721

R3 SCREW-IN TRIAL LINER 20¿6/58

Smith & Nephew, Inc.

Femoral head prosthesis trial
Primary Device ID00885556663721
NIH Device Record Key114fa56d-d2a4-4712-88b0-380f22f195c2
Commercial Distribution StatusIn Commercial Distribution
Brand NameR2
Version Model NumberE0015228-13
Catalog NumberE0015228-13
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
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
GS100885556663721 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JDIProsthesis, hip, semi-constrained, metal/polymer, cemented

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00885556663721]

Moist Heat or Steam Sterilization


[00885556663721]

Moist Heat or Steam Sterilization


[00885556663721]

Moist Heat or Steam Sterilization


[00885556663721]

Moist Heat or Steam Sterilization


[00885556663721]

Moist Heat or Steam Sterilization


[00885556663721]

Moist Heat or Steam Sterilization


[00885556663721]

Moist Heat or Steam Sterilization


[00885556663721]

Moist Heat or Steam Sterilization


[00885556663721]

Moist Heat or Steam Sterilization


[00885556663721]

Moist Heat or Steam Sterilization


[00885556663721]

Moist Heat or Steam Sterilization


[00885556663721]

Moist Heat or Steam Sterilization


[00885556663721]

Moist Heat or Steam Sterilization


[00885556663721]

Moist Heat or Steam Sterilization


[00885556663721]

Moist Heat or Steam Sterilization


[00885556663721]

Moist Heat or Steam Sterilization


[00885556663721]

Moist Heat or Steam Sterilization


[00885556663721]

Moist Heat or Steam Sterilization


[00885556663721]

Moist Heat or Steam Sterilization


[00885556663721]

Moist Heat or Steam Sterilization


[00885556663721]

Moist Heat or Steam Sterilization


[00885556663721]

Moist Heat or Steam Sterilization


[00885556663721]

Moist Heat or Steam Sterilization


[00885556663721]

Moist Heat or Steam Sterilization


[00885556663721]

Moist Heat or Steam Sterilization


[00885556663721]

Moist Heat or Steam Sterilization


[00885556663721]

Moist Heat or Steam Sterilization


[00885556663721]

Moist Heat or Steam Sterilization


[00885556663721]

Moist Heat or Steam Sterilization


[00885556663721]

Moist Heat or Steam Sterilization


[00885556663721]

Moist Heat or Steam Sterilization


[00885556663721]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-02-07
Device Publish Date2016-10-24

Devices Manufactured by Smith & Nephew, Inc.

00885556880876 - EVOS2025-02-28 EVOS 2.7MM STAGGERED PATELLA PLATE
00885556880883 - EVOS2025-02-28 EVOS 2.7MM SPLIT PATELLA PLATE
00885556886403 - EVOS2025-02-28 EVOS 2.7MM MESH PATELLA PLATE - SMALL
00885556886410 - EVOS2025-02-28 EVOS 2.7MM MESH PATELLA PLATE - LARGE
23596010587682 - FOOTPRINT2025-01-10 REPLACEMENT END CAPS FOR MALLET SET OF 2
00885556905463 - NA2024-12-25 INSERT TRIAL PITCHFORK
00885556915288 - NA2024-12-25 LM/RL TIBIA ALIGNMENT GUIDE SHORT
00885556921517 - Trigen2024-12-10 Swivel Guide Bolt Wrench

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