JII E0017149-1

GUDID 00885556795248

2MM FEMORAL RECUT BLOCK

Smith & Nephew, Inc.

Osteotomy guide, reusable Osteotomy guide, reusable Osteotomy guide, reusable Osteotomy guide, reusable Osteotomy guide, reusable Osteotomy guide, reusable Osteotomy guide, reusable Osteotomy guide, reusable Osteotomy guide, reusable Osteotomy guide, reusable Osteotomy guide, reusable Osteotomy guide, reusable Osteotomy guide, reusable Osteotomy guide, reusable
Primary Device ID00885556795248
NIH Device Record Key784d79da-b64c-4367-aa55-81335da92b23
Commercial Distribution StatusIn Commercial Distribution
Brand NameJII
Version Model NumberE0017149-1
Catalog NumberE0017149-1
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100885556795248 [Primary]
GS100885556795248 [Primary]
GS100885556795248 [Primary]
GS100885556795248 [Primary]
GS100885556795248 [Primary]
GS100885556795248 [Primary]
GS100885556795248 [Primary]
GS100885556795248 [Primary]
GS100885556795248 [Primary]
GS100885556795248 [Primary]
GS100885556795248 [Primary]
GS100885556795248 [Primary]
GS100885556795248 [Primary]
GS100885556795248 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

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

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00885556795248]

Moist Heat or Steam Sterilization


[00885556795248]

Moist Heat or Steam Sterilization


[00885556795248]

Moist Heat or Steam Sterilization


[00885556795248]

Moist Heat or Steam Sterilization


[00885556795248]

Moist Heat or Steam Sterilization


[00885556795248]

Moist Heat or Steam Sterilization


[00885556795248]

Moist Heat or Steam Sterilization


[00885556795248]

Moist Heat or Steam Sterilization


[00885556795248]

Moist Heat or Steam Sterilization


[00885556795248]

Moist Heat or Steam Sterilization


[00885556795248]

Moist Heat or Steam Sterilization


[00885556795248]

Moist Heat or Steam Sterilization


[00885556795248]

Moist Heat or Steam Sterilization


[00885556795248]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-10-15
Device Publish Date2020-10-07

On-Brand Devices [JII]

00885556741597IM TIBIAL STYLUS ASSEMBLY
00885556740422IM ROD SHORT
00885556740415IM ROD LONG
00885556740408SEVEN DEGREE VALGUS COLLET
00885556740392SIX DEGREE VALGUS COLLET
00885556740385FIVE DEGREE VALGUS COLLET
00885556740378FOUR DEGREE VALGUS COLLET
00885556740361ADJUSTABLE VALGUS GUIDE
00885556740354FIXED VALGUS GUIDE
00885556740347FIXED VALGUS BRIDGE
00885556740330DISTAL FEMORAL CUTTING BLOCK
00885556738566JII BCS TRIAL INSERT 7-8 12MM R
00885556738559JII BCS TRIAL INSERT 7-8 11MM R
00885556738542JII BCS TRIAL INSERT 7-8 10MM R
00885556738535JII BCS TRIAL INSERT 7-8 9MM R
00885556738528JII BCS TRIAL INSERT 5-6 12MM R
00885556738511JII BCS TRIAL INSERT 5-6 11MM R
00885556738504JII BCS TRIAL INSERT 5-6 10MM R
00885556738498JII BCS TRIAL INSERT 5-6 9MM R
00885556738481JII BCS TRIAL INSERT 3-4 12MM R
00885556738474JII BCS TRIAL INSERT 3-4 11MM R
00885556738467JII BCS TRIAL INSERT 3-4 10MM R
00885556738450JII BCS TRIAL INSERT 3-4 9MM R
00885556738443JII BCS TRIAL INSERT 1-2 12MM R
00885556738436JII BCS TRIAL INSERT 1-2 11MM R
00885556738429JII BCS TRIAL INSERT 1-2 10MM R
00885556738412JII BCS TRIAL INSERT SZ 1-2 9MM R
00885556738405PITCHFORK HANDLE FOR TRIAL INSERTS
00885556738399JII BCS TRIAL INSERT 7-8 12MM L
00885556738382JII BCS TRIAL INSERT 7-8 11MM L
00885556738368JII BCS TRIAL INSERT 7-8 10MM L
00885556738344JII BCS TRIAL INSERT 7-8 9MM L
00885556738320JII BCS TRIAL INSERT 5-6 12MM L
00885556738306JII BCS TRIAL INSERT 5-6 11MM L
00885556738290JII BCS TRIAL INSERT 5-6 10MM L
00885556738276JII BCS TRIAL INSERT 5-6 9MM L
00885556738269JII BCS TRIAL INSERT 3-4 12MM L
00885556738245JII BCS TRIAL INSERT 3-4 11MM L
00885556738221JII BCS TRIAL INSERT 3-4 10MM L
00885556738214JII BCS TRIAL INSERT 3-4 9MM L
00885556738191JII BCS TRIAL INSERT SZ 1-2 12MM L
00885556738184JII BCS TRIAL INSERT SZ 1-2 11MM L
00885556738177JII BCS TRIAL INSERT SZ 1-2 10MM L
00885556738160JII BCS TRIAL INSERT SZ 1-2 9MM L
00885556738092JII DD TRIAL INSERT 7-8 12MM R
00885556738085JII DD TRIAL INSERT 7-8 11MM R
00885556738078JII DD TRIAL INSERT 7-8 10MM R
00885556738061JII DD TRIAL INSERT 7-8 9MM R
00885556738054JII DD TRIAL INSERT 5-6 12MM R
00885556738047JII DD TRIAL INSERT 5-6 11MM R

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