J2 E0016329-8

GUDID 00885556737491

J2 DD TRIAL INSERT 7-8 12MM L

Smith & Nephew, Inc.

Knee tibia prosthesis trial
Primary Device ID00885556737491
NIH Device Record Key4a9023b6-4692-4d42-b541-34658b3c569c
Commercial Distribution StatusIn Commercial Distribution
Brand NameJ2
Version Model NumberE0016329-8
Catalog NumberE0016329-8
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100885556737491 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JWHPROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00885556737491]

Moist Heat or Steam Sterilization


[00885556737491]

Moist Heat or Steam Sterilization


[00885556737491]

Moist Heat or Steam Sterilization


[00885556737491]

Moist Heat or Steam Sterilization


[00885556737491]

Moist Heat or Steam Sterilization


[00885556737491]

Moist Heat or Steam Sterilization


[00885556737491]

Moist Heat or Steam Sterilization


[00885556737491]

Moist Heat or Steam Sterilization


[00885556737491]

Moist Heat or Steam Sterilization


[00885556737491]

Moist Heat or Steam Sterilization


[00885556737491]

Moist Heat or Steam Sterilization


[00885556737491]

Moist Heat or Steam Sterilization


[00885556737491]

Moist Heat or Steam Sterilization


[00885556737491]

Moist Heat or Steam Sterilization


[00885556737491]

Moist Heat or Steam Sterilization


[00885556737491]

Moist Heat or Steam Sterilization


[00885556737491]

Moist Heat or Steam Sterilization


[00885556737491]

Moist Heat or Steam Sterilization


[00885556737491]

Moist Heat or Steam Sterilization


[00885556737491]

Moist Heat or Steam Sterilization


[00885556737491]

Moist Heat or Steam Sterilization


[00885556737491]

Moist Heat or Steam Sterilization


[00885556737491]

Moist Heat or Steam Sterilization


[00885556737491]

Moist Heat or Steam Sterilization


[00885556737491]

Moist Heat or Steam Sterilization


[00885556737491]

Moist Heat or Steam Sterilization


[00885556737491]

Moist Heat or Steam Sterilization


[00885556737491]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-02-11
Device Publish Date2019-01-11

On-Brand Devices [J2]

00885556737538J2 DD TRIAL INSERT 7-8 12MM R
00885556737521J2 DD TRIAL INSERT 7-8 11MM R
00885556737514J2 DD TRIAL INSERT 7-8 10MM R
00885556737507J2 DD TRIAL INSERT 7-8 9MM R
00885556737491J2 DD TRIAL INSERT 7-8 12MM L
00885556737484J2 DD TRIAL INSERT 7-8 11MM L
00885556737477J2 DD TRIAL INSERT 7-8 10MM L
00885556737460J2 DD TRIAL INSERT 7-8 9MM L
00885556737453J2 DD TRIAL INSERT 5-6 9MM R
00885556737446J2 DD TRIAL INSERT 5-6 9MM L
00885556737439J2 DD TRIAL INSERT 1-2 9MM R
00885556737422J2 DD TRIAL INSERT 1-2 9MM L

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