SURFIXTotal Wrist Fusion 286212ND

GUDID 00885556819647

SCREW AND LOCK SCREW - STAINLESS STEEL DIA. 2.7MM L.12MM

Smith & Nephew, Inc.

Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding)
Primary Device ID00885556819647
NIH Device Record Keyd885bb32-ef42-4f79-a335-98acea886147
Commercial Distribution StatusIn Commercial Distribution
Brand NameSURFIXTotal Wrist Fusion
Version Model Number286212ND
Catalog Number286212ND
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 Datetrue
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
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
GS100885556819647 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HRSPlate, fixation, bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00885556819647]

Moist Heat or Steam Sterilization

[00885556819647]

Moist Heat or Steam Sterilization

[00885556819647]

Moist Heat or Steam Sterilization

[00885556819647]

Moist Heat or Steam Sterilization

[00885556819647]

Moist Heat or Steam Sterilization

[00885556819647]

Moist Heat or Steam Sterilization

[00885556819647]

Moist Heat or Steam Sterilization

[00885556819647]

Moist Heat or Steam Sterilization

[00885556819647]

Moist Heat or Steam Sterilization

[00885556819647]

Moist Heat or Steam Sterilization

[00885556819647]

Moist Heat or Steam Sterilization

[00885556819647]

Moist Heat or Steam Sterilization

[00885556819647]

Moist Heat or Steam Sterilization

[00885556819647]

Moist Heat or Steam Sterilization

[00885556819647]

Moist Heat or Steam Sterilization

[00885556819647]

Moist Heat or Steam Sterilization

[00885556819647]

Moist Heat or Steam Sterilization

[00885556819647]

Moist Heat or Steam Sterilization

[00885556819647]

Moist Heat or Steam Sterilization

[00885556819647]

Moist Heat or Steam Sterilization

[00885556819647]

Moist Heat or Steam Sterilization

[00885556819647]

Moist Heat or Steam Sterilization

[00885556819647]

Moist Heat or Steam Sterilization

[00885556819647]

Moist Heat or Steam Sterilization

[00885556819647]

Moist Heat or Steam Sterilization

[00885556819647]

Moist Heat or Steam Sterilization

[00885556819647]

Moist Heat or Steam Sterilization

[00885556819647]

Moist Heat or Steam Sterilization

[00885556819647]

Moist Heat or Steam Sterilization

[00885556819647]

Moist Heat or Steam Sterilization

[00885556819647]

Moist Heat or Steam Sterilization

[00885556819647]

Moist Heat or Steam Sterilization

[00885556819647]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-11-02
Device Publish Date2023-10-25

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00885556747407 - FASTPAK2024-06-21 FASTPAK TIBIAL BASE TRIAL SIZE 1 RIGHT
00885556747414 - FASTPAK2024-06-21 FASTPAK TIBIAL BASE TRIAL SIZE 2 RIGHT
00885556747421 - FASTPAK2024-06-21 FASTPAK TIBIAL BASE TRIAL SIZE 3 RIGHT
00885556747438 - FASTPAK2024-06-21 FASTPAK TIBIAL BASE TRIAL SIZE 4 RIGHT
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