Internal Fix E0016908-1

GUDID 00885556778890

2.5MM TARGETER DRILL GUIDE

Smith & Nephew, Inc.

Surgical drill guide, reusable
Primary Device ID00885556778890
NIH Device Record Key4f109e23-bf13-43fb-a46b-05c64877758f
Commercial Distribution StatusIn Commercial Distribution
Brand NameInternal Fix
Version Model NumberE0016908-1
Catalog NumberE0016908-1
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100885556778890 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HRSPlate, fixation, bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00885556778890]

Moist Heat or Steam Sterilization


[00885556778890]

Moist Heat or Steam Sterilization


[00885556778890]

Moist Heat or Steam Sterilization


[00885556778890]

Moist Heat or Steam Sterilization


[00885556778890]

Moist Heat or Steam Sterilization


[00885556778890]

Moist Heat or Steam Sterilization


[00885556778890]

Moist Heat or Steam Sterilization


[00885556778890]

Moist Heat or Steam Sterilization


[00885556778890]

Moist Heat or Steam Sterilization


[00885556778890]

Moist Heat or Steam Sterilization


[00885556778890]

Moist Heat or Steam Sterilization


[00885556778890]

Moist Heat or Steam Sterilization


[00885556778890]

Moist Heat or Steam Sterilization


[00885556778890]

Moist Heat or Steam Sterilization


[00885556778890]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-03-09
Device Publish Date2020-02-28

On-Brand Devices [Internal Fix]

008855567789202.5MM HEX TARGETER DRIVER
008855567789132.5MM TARGETER DRILL BIT
008855567789063.5MM TARGETER DEPTH GAUGE
008855567788902.5MM TARGETER DRILL GUIDE
00885556779972CANNULATED DEPTH GAUGE
00885556773840GUIDE PIN SLEEVE - STRAIGHT HANDLE
00885556794593EXTENDED T8 DRIVER SHAFT
00885556794586EXTENDED T7 DRIVER SHAFT
00885556794579EXTENDED T6 DRIVER SHAFT
00885556794340CABLE PASSER - LARGE
00885556794333CABLE PASSER - SMALL
00885556802496PLATE BENDING PLIERS - 2.7
00885556802489PLATE BENDING PLIERS - 2.4
00885556802472PLATE BENDING PLIERS - 2.0
00885556802519PLATE BENDING PLIERS - 2.0
00885556802533PLATE BENDING PLIERS - 2.7
00885556802526PLATE BENDING PLIERS - 2.4
008855568046983.5MM TARGETER DEPTH GAUGE
00885556804681EXTRA LONG 2.5MM HEX TARGETER DRIVER
008855568790852.5MM PUSH SCREW SLEEVE
008855568790782.5MM SHORT PUSH SCREW SHAFT
00885556886311EXTENDED T6 LINEAR DRIVER SHAFT
00885556886304EXTENDED T8 HOLDING SLEEVE
00885556886298EXTENDED T7 HOLDING SLEEVE
00885556886281EXTENDED T6 HOLDING SLEEVE
00885556886335EXTENDED T8 LINEAR DRIVER SHAFT
00885556886328EXTENDED T7 LINEAR DRIVER SHAFT

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