First Choice Modular Ulnar Head Implant TRL-600-H160

GUDID 00885556826584

MUH HEAD TRIAL SZ. 16

Smith & Nephew, Inc.

Surgical implant template, reusable
Primary Device ID00885556826584
NIH Device Record Key29a3745a-d5de-4c9f-b64e-b5b797b4701d
Commercial Distribution StatusIn Commercial Distribution
Brand NameFirst Choice Modular Ulnar Head Implant
Version Model NumberTRL-600-H160
Catalog NumberTRL-600-H160
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 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
GS100885556826584 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KXEProsthesis, wrist, hemi-, ulnar

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00885556826584]

Moist Heat or Steam Sterilization


[00885556826584]

Moist Heat or Steam Sterilization


[00885556826584]

Moist Heat or Steam Sterilization


[00885556826584]

Moist Heat or Steam Sterilization


[00885556826584]

Moist Heat or Steam Sterilization


[00885556826584]

Moist Heat or Steam Sterilization


[00885556826584]

Moist Heat or Steam Sterilization


[00885556826584]

Moist Heat or Steam Sterilization


[00885556826584]

Moist Heat or Steam Sterilization


[00885556826584]

Moist Heat or Steam Sterilization


[00885556826584]

Moist Heat or Steam Sterilization


[00885556826584]

Moist Heat or Steam Sterilization


[00885556826584]

Moist Heat or Steam Sterilization


[00885556826584]

Moist Heat or Steam Sterilization


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 Modular Ulnar Head Implant]

00885556826324MUH OSTEOTOMY GUIDE
00885556826317MUH RESECTION GUIDE
00885556826171MUH STEM IMPACTOR
00885556826089MUH REAMER SZ. 6.5
00885556826072MUH REAMER SZ. 5.5
00885556826065MUH REAMER SZ. 4.5
00885556826058MUH REAMER SZ. 3.5
00885556826300MUH STEM SZ. 6.5 S
00885556826294MUH STEM SZ. 6.5 M
00885556826287MUH STEM SZ. 6.5 L
00885556826270MUH STEM SZ. 5.5 S
00885556826263MUH STEM SZ. 5.5 M
00885556826256MUH STEM SZ. 5.5 L
00885556826249MUH STEM SZ. 4.5 S
00885556826232MUH STEM SZ. 4.5 M
00885556826225MUH STEM SZ. 4.5 L
00885556826218MUH HEAD SZ. 19.0
00885556826201MUH HEAD SZ. 17.5
00885556826195MUH HEAD SZ. 16.0
00885556826652MUH STEM TRIAL SZ. 6.5
00885556826645MUH STEM TRIAL SZ. 5.5
00885556826638MUH STEM TRIAL SZ. 4.5
00885556826614MUH TRIAL COLLAR LONG
00885556826607MUH HEAD TRIAL SZ. 19
00885556826591MUH HEAD TRIAL SZ. 17.5
00885556826584MUH HEAD TRIAL SZ. 16
00885556826188MUH BACK TABLE ASSY PAD
00885556826096MUH INSTRUMENT CASE BASE

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