GII E0016985-1

GUDID 00885556786925

NON-ROTATING ANGLED FEMORAL STYLUS

Smith & Nephew, Inc.

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Primary Device ID00885556786925
NIH Device Record Keyd62e4916-8922-4963-b1f1-2f43a32e8ca1
Commercial Distribution StatusIn Commercial Distribution
Brand NameGII
Version Model NumberE0016985-1
Catalog NumberE0016985-1
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100885556786925 [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

[00885556786925]

Moist Heat or Steam Sterilization


[00885556786925]

Moist Heat or Steam Sterilization


[00885556786925]

Moist Heat or Steam Sterilization


[00885556786925]

Moist Heat or Steam Sterilization


[00885556786925]

Moist Heat or Steam Sterilization


[00885556786925]

Moist Heat or Steam Sterilization


[00885556786925]

Moist Heat or Steam Sterilization


[00885556786925]

Moist Heat or Steam Sterilization


[00885556786925]

Moist Heat or Steam Sterilization


[00885556786925]

Moist Heat or Steam Sterilization


[00885556786925]

Moist Heat or Steam Sterilization


[00885556786925]

Moist Heat or Steam Sterilization


[00885556786925]

Moist Heat or Steam Sterilization


[00885556786925]

Moist Heat or Steam Sterilization


[00885556786925]

Moist Heat or Steam Sterilization


[00885556786925]

Moist Heat or Steam Sterilization


[00885556786925]

Moist Heat or Steam Sterilization


[00885556786925]

Moist Heat or Steam Sterilization


[00885556786925]

Moist Heat or Steam Sterilization


[00885556786925]

Moist Heat or Steam Sterilization


[00885556786925]

Moist Heat or Steam Sterilization


[00885556786925]

Moist Heat or Steam Sterilization


[00885556786925]

Moist Heat or Steam Sterilization


[00885556786925]

Moist Heat or Steam Sterilization


[00885556786925]

Moist Heat or Steam Sterilization


[00885556786925]

Moist Heat or Steam Sterilization


[00885556786925]

Moist Heat or Steam Sterilization


[00885556786925]

Moist Heat or Steam Sterilization


[00885556786925]

Moist Heat or Steam Sterilization


[00885556786925]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-06-11
Device Publish Date2020-06-03

On-Brand Devices [GII]

00885556741252GII PS HIGH FLEX INSERT 7-8 12MM
00885556741245GII PS HIGH FLEX INSERT 7-8 11MM
00885556741238GII PS HIGH FLEX INSERT 7-8 10MM
00885556741221GII PS HIGH FLEX INSERT 7-8 9MM
00885556741214GII PS HIGH FLEX INSERT 5-6 12MM
00885556741207GII PS HIGH FLEX INSERT 5-6 11MM
00885556741191GII PS HIGH FLEX INSERT 5-6 10MM
00885556741184GII PS HIGH FLEX INSERT 5-6 9MM
00885556741177GII PS HIGH FLEX INSERT 3-4 12MM
00885556741160GII PS HIGH FLEX INSERT 3-4 11MM
00885556741153GII PS HIGH FLEX INSERT 3-4 10MM
00885556741146GII PS HIGH FLEX INSERT 3-4 9MM
00885556741139GII PS HIGH FLEX INSERT 1-2 12MM
00885556741122GII PS HIGH FLEX INSERT 1-2 11MM
00885556741115GII PS HIGH FLEX INSERT 1-2 10MM
00885556741108GII PS HIGH FLEX INSERT 1-2 9MM
00885556740316GII CONST. ARTICULAR INSERT 7-8 11MM
00885556740309GII CONST. ARTICULAR INSERT 7-8 9MM
00885556740293GII CONST. ARTICULAR INSERT 5-6 11MM
00885556740286GII CONST. ARTICULAR INSERT 5-6 9MM
00885556740279GII CONST. ARTICULAR INSERT 3-4 11MM
00885556740262GII CONST. ARTICULAR INSERT 3-4 9MM
00885556740255GII CONST. ARTICULAR INSERT 1-2 11MM
00885556740248GII CONST. ARTICULAR INSERT 1-2 9MM
00885556740231GII DISH ARTICULAR INSERT 7-8 11MM
00885556740224GII DISH ARTICULAR INSERT 7-8 9MM
00885556740217GII DISH ARTICULAR INSERT 5-6 11MM
00885556740200GII DISH ARTICULAR INSERT 5-6 9MM
00885556740194GII DISH ARTICULAR INSERT 3-4 11MM
00885556740187GII DISH ARTICULAR INSERT 3-4 9MM
00885556740170GII DISH ARTICULAR INSERT 1-2 11MM
00885556740163GII DISH ARTICULAR INSERT 1-2 9MM
00885556740156GII CR DEEP FLEX INSERT TRIAL 7-8 12MM
00885556740149GII CR DEEP FLEX INSERT TRIAL 7-8 11MM
00885556740132GII CR DEEP FLEX INSERT TRIAL 7-8 10MM
00885556740125GII CR DEEP FLEX INSERT TRIAL 7-8 9MM
00885556740118GII CR DEEP FLEX INSERT TRIAL 5-6 12MM
00885556740101GII CR DEEP FLEX INSERT TRIAL 5-6 11MM
00885556740095GII CR DEEP FLEX INSERT TRIAL 5-6 10MM
00885556740088GII CR DEEP FLEX INSERT TRIAL 5-6 9MM
00885556740071GII CR DEEP FLEX INSERT TRIAL 3-4 12MM
00885556740064GII CR DEEP FLEX INSERT TRIAL 3-4 11MM
00885556740057GII CR DEEP FLEX INSERT TRIAL 3-4 10MM
00885556740040GII CR DEEP FLEX INSERT TRIAL 3-4 9MM
00885556740033GII CR DEEP FLEX INSERT TRIAL 1-2 12MM
00885556740026GII CR DEEP FLEX INSERT TRIAL 1-2 11MM
00885556740019GII CR DEEP FLEX INSERT TRIAL 1-2 10MM
00885556740002GII CR DEEP FLEX INSERT TRIAL 1-2 9MM
00885556739990PITCHFORK HANDLE
00885556739983GII CR FEMORAL IMPACTOR

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