First Choice Partial Ulnar Head Implant DRUJ-610-1465-WW

GUDID 00885556826485

FIRST CHOICE HEAD 14.5-STEM 6.5

Smith & Nephew, Inc.

Surgical implant template, reusable
Primary Device ID00885556826485
NIH Device Record Keye8def5e0-d96d-4181-956c-8f9e7541b83b
Commercial Distribution StatusIn Commercial Distribution
Brand NameFirst Choice Partial Ulnar Head Implant
Version Model NumberDRUJ-610-1465-WW
Catalog NumberDRUJ-610-1465-WW
Company DUNS045483575
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
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
GS100885556826485 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KXEProsthesis, wrist, hemi-, ulnar

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2023-09-07
Device Publish Date2022-12-21

On-Brand Devices [First Choice Partial Ulnar Head Implant]

00885556826331DRUJ OSTEOTOMY GUIDE
00885556826577FIRST CHOICE HEAD 19.0-STEM 6.5
00885556826560FIRST CHOICE HEAD 19.0-STEM 5.5
00885556826553FIRST CHOICE HEAD 19.0-STEM 4.5
00885556826546FIRST CHOICE HEAD 17.5-STEM 6.5
00885556826539FIRST CHOICE HEAD 17.5-STEM 5.5
00885556826522FIRST CHOICE HEAD 17.5-STEM 4.5
00885556826515FIRST CHOICE HEAD 16.0-STEM 6.5
00885556826508FIRST CHOICE HEAD 16.0-STEM 5.5
00885556826492FIRST CHOICE HEAD 16.0-STEM 4.5
00885556826485FIRST CHOICE HEAD 14.5-STEM 6.5
00885556826478FIRST CHOICE HEAD 14.5-STEM 5.5
00885556826461FIRST CHOICE HEAD 14.5-STEM 4.5
00885556826454DRUJ TRIAL SZ. 190-65
00885556826447DRUJ TRIAL SZ. 190-55
00885556826430DRUJ TRIAL SZ. 190-45
00885556826423DRUJ TRIAL SZ. 175-65
00885556826416DRUJ TRIAL SZ. 175-55
00885556826409DRUJ TRIAL SZ. 175-45
00885556826393DRUJ TRIAL SZ. 160-65
00885556826386DRUJ TRIAL SZ. 160-55
00885556826379DRUJ TRIAL SZ. 160-45
00885556826362DRUJ TRIAL SZ. 145-65
00885556826355DRUJ TRIAL SZ. 145-55
00885556826348DRUJ TRIAL SZ. 145-45
00885556826119FIRST CHOICE/DRUJ SYSTEM TAG
00885556826102FIRST CHOICE INSERT

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