72203460

GUDID 00885554028041

OBTURATOR TROC TIP FLEX CRVD GUIDE

Smith & Nephew, Inc.

Surgical drill guide obturator
Primary Device ID00885554028041
NIH Device Record Keyd241eab9-b0c4-4afa-b237-b25dc3acb06e
Commercial Distribution StatusIn Commercial Distribution
Version Model Number72203460
Catalog Number72203460
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)821-5700
Emailgudid@smith-nephew.com
Phone+1(800)821-5700
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
GS100885554028041 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MBIFASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00885554028041]

Moist Heat or Steam Sterilization


[00885554028041]

Moist Heat or Steam Sterilization


[00885554028041]

Moist Heat or Steam Sterilization


[00885554028041]

Moist Heat or Steam Sterilization


[00885554028041]

Moist Heat or Steam Sterilization


[00885554028041]

Moist Heat or Steam Sterilization


[00885554028041]

Moist Heat or Steam Sterilization


[00885554028041]

Moist Heat or Steam Sterilization


[00885554028041]

Moist Heat or Steam Sterilization


[00885554028041]

Moist Heat or Steam Sterilization


[00885554028041]

Moist Heat or Steam Sterilization


[00885554028041]

Moist Heat or Steam Sterilization


[00885554028041]

Moist Heat or Steam Sterilization


[00885554028041]

Moist Heat or Steam Sterilization


[00885554028041]

Moist Heat or Steam Sterilization


[00885554028041]

Moist Heat or Steam Sterilization


[00885554028041]

Moist Heat or Steam Sterilization


[00885554028041]

Moist Heat or Steam Sterilization


[00885554028041]

Moist Heat or Steam Sterilization


[00885554028041]

Moist Heat or Steam Sterilization


[00885554028041]

Moist Heat or Steam Sterilization


[00885554028041]

Moist Heat or Steam Sterilization


[00885554028041]

Moist Heat or Steam Sterilization


[00885554028041]

Moist Heat or Steam Sterilization


[00885554028041]

Moist Heat or Steam Sterilization


[00885554028041]

Moist Heat or Steam Sterilization


[00885554028041]

Moist Heat or Steam Sterilization


[00885554028041]

Moist Heat or Steam Sterilization


[00885554028041]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-01-31
Device Publish Date2015-08-29

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00885556915264 - NA2025-12-30 EM TIBIA ALIGNMENT TUBE MICRO SHORT
00885556915271 - NA2025-12-30 MACRO EM TIBIA ALIGNMENT TUBE SHORT
00885556915295 - NA2025-12-30 RM/LL TIBIA ALIGNMENT GUIDE SHORT
00885556915301 - NA2025-12-30 TIBIA ALIGNMENT ADJUSTMENT GUIDE SHORT
00885556915318 - NA2025-12-30 SYNC SHORT EXTRAMEDULLARY GUIDES MODULE
00885556900260 - TRIGEN MAX2025-12-26 TRIGEN MAX BUTTRESS PLATE - TI

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