71933587

GUDID 00885556062555

LOCKING DRILL GUIDE

Smith & Nephew, Inc.

Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable
Primary Device ID00885556062555
NIH Device Record Keyc3dbb2a5-c725-483a-8f2e-42090cc6b569
Commercial Distribution StatusIn Commercial Distribution
Version Model Number71933587
Catalog Number71933587
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
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
GS100885556062555 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HRSPLATE, FIXATION, BONE

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00885556062555]

Moist Heat or Steam Sterilization


[00885556062555]

Moist Heat or Steam Sterilization


[00885556062555]

Moist Heat or Steam Sterilization


[00885556062555]

Moist Heat or Steam Sterilization


[00885556062555]

Moist Heat or Steam Sterilization


[00885556062555]

Moist Heat or Steam Sterilization


[00885556062555]

Moist Heat or Steam Sterilization


[00885556062555]

Moist Heat or Steam Sterilization


[00885556062555]

Moist Heat or Steam Sterilization


[00885556062555]

Moist Heat or Steam Sterilization


[00885556062555]

Moist Heat or Steam Sterilization


[00885556062555]

Moist Heat or Steam Sterilization


[00885556062555]

Moist Heat or Steam Sterilization


[00885556062555]

Moist Heat or Steam Sterilization


[00885556062555]

Moist Heat or Steam Sterilization


[00885556062555]

Moist Heat or Steam Sterilization


[00885556062555]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-11-22
Device Publish Date2015-08-29

Devices Manufactured by Smith & Nephew, Inc.

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00885556747377 - FASTPAK2024-06-21 FASTPAK TIBIAL BASE TRIAL SIZE 3 LEFT
00885556747384 - FASTPAK2024-06-21 FASTPAK TIBIAL BASE TRIAL SIZE 5 LEFT
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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