Ascension MCP Joint Replacement MCP-100-50P-WW

GUDID 00885556856802

MCP SZ. 50 PROXIMAL WW

Smith & Nephew, Inc.

Metacarpophalangeal joint prosthesis, modular Metacarpophalangeal joint prosthesis, modular Metacarpophalangeal joint prosthesis, modular Metacarpophalangeal joint prosthesis, modular Metacarpophalangeal joint prosthesis, modular Metacarpophalangeal joint prosthesis, modular Metacarpophalangeal joint prosthesis, modular Metacarpophalangeal joint prosthesis, modular Metacarpophalangeal joint prosthesis, modular Metacarpophalangeal joint prosthesis, modular Metacarpophalangeal joint prosthesis, modular Metacarpophalangeal joint prosthesis, modular Metacarpophalangeal joint prosthesis, modular Metacarpophalangeal joint prosthesis, modular Metacarpophalangeal joint prosthesis, modular Metacarpophalangeal joint prosthesis, modular Metacarpophalangeal joint prosthesis, modular Metacarpophalangeal joint prosthesis, modular Metacarpophalangeal joint prosthesis, modular Metacarpophalangeal joint prosthesis, modular Metacarpophalangeal joint prosthesis, modular Metacarpophalangeal joint prosthesis, modular Metacarpophalangeal joint prosthesis, modular Metacarpophalangeal joint prosthesis, modular Metacarpophalangeal joint prosthesis, modular Metacarpophalangeal joint prosthesis, modular Metacarpophalangeal joint prosthesis, modular Metacarpophalangeal joint prosthesis, modular
Primary Device ID00885556856802
NIH Device Record Key8d5e71dc-2a7d-4226-bbc7-76670847b824
Commercial Distribution StatusIn Commercial Distribution
Brand NameAscension MCP Joint Replacement
Version Model NumberMCP-100-50P-WW
Catalog NumberMCP-100-50P-WW
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 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
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
GS100885556856802 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NEGFinger semi-constrained pyrolytic carbon uncemented prosthesis

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2023-04-04
Device Publish Date2022-12-22

On-Brand Devices [Ascension MCP Joint Replacement]

00885556856673MCP. EXTRACTOR. IMPLANT
00885556856611MCP PROXIMAL CUTTING BROACH SZ. 05
00885556856604MCP DISTAL CUTTING BROACH SZ. 05
00885556856598MCP. BROACH. PROXIMAL. SZ. 50
00885556856581MCP. BROACH. DISTAL. SZ. 50
00885556856574MCP. BROACH. PROXIMAL. SZ. 40
00885556856567MCP. BROACH. DISTAL. SZ. 40
00885556856550MCP. BROACH. PROXIMAL. SZ. 30
00885556856543MCP. BROACH. DISTAL. SZ. 30
00885556856536MCP. BROACH. PROXIMAL. SZ. 20
00885556856529MCP. BROACH. DISTAL. SZ. 20
00885556856512MCP. BROACH. PROXIMAL. SZ. 10
00885556856505MCP. BROACH. DISTAL. SZ. 10
00885556856482AWL. STARTER
00885556856826MCP SZ. 05 PROXIMAL WW
00885556856802MCP SZ. 50 PROXIMAL WW
00885556856789MCP SZ. 40 PROXIMAL WW
00885556856765MCP SZ. 30 PROXIMAL WW
00885556856741MCP SZ. 20 PROXIMAL WW
00885556856727MCP SZ. 10 PROXIMAL WW
00885556856840MCP DISPOSABLE PACK FOR STRYKER
00885556856833MCP DISPOSABLE PACK FOR LINVATEC/HALL
00885556857076MCP PROXIMAL METAL TRIAL SZ. 50
00885556857069MCP DISTAL METAL TRIAL SZ. 50
00885556857052MCP PROXIMAL METAL TRIAL SZ. 40
00885556857045MCP DISTAL METAL TRIAL SZ. 40
00885556857038MCP PROXIMAL METAL TRIAL SZ. 30
00885556857021MCP DISTAL METAL TRIAL SZ. 30
00885556857014MCP PROXIMAL METAL TRIAL SZ. 20
00885556857007MCP DISTAL METAL TRIAL SZ. 20
00885556856994MCP PROXIMAL METAL TRIAL SZ. 10
00885556856987MCP DISTAL METAL TRIAL SZ. 10
00885556856970MCP PROXIMAL METAL TRIAL SZ. 05
00885556856963MCP DISTAL METAL TRIAL SZ. 05
00885556856864MCP. OSTEOTOMY GUIDE. PROXIMAL
00885556856857MCP. OSTEOTOMY GUIDE. DISTAL
00885556856819MCP SZ. 05 DISTAL WW
00885556856796MCP SZ. 50 DISTAL WW
00885556856772MCP SZ. 40 DISTAL WW
00885556856758MCP SZ. 30 DISTAL WW
00885556856734MCP SZ. 20 DISTAL WW
00885556856710MCP SZ. 10 DISTAL WW
00885556856703MCP. IMPACTOR. PROXIMAL
00885556856697MCP. IMPACTOR. DISTAL
00885556856666MCP CADDY SZ. 05-40
00885556856659MCP BASE SZ. 05-40
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.