Trauma - Misc E0015743-2

GUDID 00885556705636

3.2MM X 450MM DRILL TIP GUIDE PINS

Smith & Nephew, Inc.

General internal orthopaedic fixation system implantation kit
Primary Device ID00885556705636
NIH Device Record Keyac973091-b739-48d6-a28d-b3df3d19da3c
Commercial Distribution StatusIn Commercial Distribution
Brand NameTrauma - Misc
Version Model NumberE0015743-2
Catalog NumberE0015743-2
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100885556705636 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HRSPlate, fixation, bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00885556705636]

Moist Heat or Steam Sterilization


[00885556705636]

Moist Heat or Steam Sterilization


[00885556705636]

Moist Heat or Steam Sterilization


[00885556705636]

Moist Heat or Steam Sterilization


[00885556705636]

Moist Heat or Steam Sterilization


[00885556705636]

Moist Heat or Steam Sterilization


[00885556705636]

Moist Heat or Steam Sterilization


[00885556705636]

Moist Heat or Steam Sterilization


[00885556705636]

Moist Heat or Steam Sterilization


[00885556705636]

Moist Heat or Steam Sterilization


[00885556705636]

Moist Heat or Steam Sterilization


[00885556705636]

Moist Heat or Steam Sterilization


[00885556705636]

Moist Heat or Steam Sterilization


[00885556705636]

Moist Heat or Steam Sterilization


[00885556705636]

Moist Heat or Steam Sterilization


[00885556705636]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-11-02

On-Brand Devices [Trauma - Misc]

00885556739297205MM FORCEPS W/ BALL TIP
00885556739181MODIFIED BLOCKING SCREW GUIDE
00885556726303CANNULATED DEPTH GAUGE
008855567248351.9MM X 300MM NON-THREADED GUIDE PIN
008855567210491.9MM X 450MM GUIDE PIN
008855567190773.2MM X 343MM SMOOTH ENDED DRILL TIP PIN
008855567190531.9MM X 300MM NON-THREADED GUIDE PIN
00885556717585CANNULATED DEPTH GAUGE
008855567175783.2MM X 450MM DRILL TIP GUIDE PIN
00885556717561CANNULATED DEPTH GAUGE
008855567175543.2MM X 450MM DRILL TIP GUIDE PIN
00885556717455MODIFIED BLOCKING SCREW GUIDE
00885556714249MODIFIED 3.2MM PARALLEL PIN GUIDE
00885556709320CANNULATED DEPTH GAUGE
008855567056363.2MM X 450MM DRILL TIP GUIDE PINS
00885556705629CANNULATED DEPTH GAUGE
008855567056123.2MM X 450MM DRILL TIP GUIDE PINS
00885556705605CANNULATED DEPTH GAUGE
008855567055372.5MM HEX DRIVER WITH LARGE HANDLE
008855567449633.4MM HEX DRIVER W/ HANDLE
008855567449562.7MM HEX DRIVER W/ HANDLE
00885556748558MODIFIED 6.5MM CANNULATED SCREW DRIVER
00885556774656205MM FORCEPS W/ BALL TIP
00885556789711LARGE BENDING PRESS LOWER ANVIL
00885556789704LARGE BENDING PRESS UPPER ANVIL
00885556791325MODIFIED BLOCKING SCREW GUIDE
00885556794630MODIFIED 6.5MM CANNULATED SCREW DRIVER
008855568713312.5MM TARGETER DRILL BIT
00885556799291EXTENDED T8 DRIVER SHAFT
00885556799284EXTENDED T7 DRIVER SHAFT
00885556799277EXTENDED T6 DRIVER SHAFT

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