72203788

GUDID 00885554029284

DRILL GUIDE SLOTTED SPIKE TIP SL-PLUS

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 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 ID00885554029284
NIH Device Record Key86eb24c9-3132-4c0a-9e87-6b89309b7f6b
Commercial Distribution StatusIn Commercial Distribution
Version Model Number72203788
Catalog Number72203788
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
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
GS100885554029284 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MBIFASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00885554029284]

Moist Heat or Steam Sterilization


[00885554029284]

Moist Heat or Steam Sterilization


[00885554029284]

Moist Heat or Steam Sterilization


[00885554029284]

Moist Heat or Steam Sterilization


[00885554029284]

Moist Heat or Steam Sterilization


[00885554029284]

Moist Heat or Steam Sterilization


[00885554029284]

Moist Heat or Steam Sterilization


[00885554029284]

Moist Heat or Steam Sterilization


[00885554029284]

Moist Heat or Steam Sterilization


[00885554029284]

Moist Heat or Steam Sterilization


[00885554029284]

Moist Heat or Steam Sterilization


[00885554029284]

Moist Heat or Steam Sterilization


[00885554029284]

Moist Heat or Steam Sterilization


[00885554029284]

Moist Heat or Steam Sterilization


[00885554029284]

Moist Heat or Steam Sterilization


[00885554029284]

Moist Heat or Steam Sterilization


[00885554029284]

Moist Heat or Steam Sterilization


[00885554029284]

Moist Heat or Steam Sterilization


[00885554029284]

Moist Heat or Steam Sterilization


[00885554029284]

Moist Heat or Steam Sterilization


[00885554029284]

Moist Heat or Steam Sterilization


[00885554029284]

Moist Heat or Steam Sterilization


[00885554029284]

Moist Heat or Steam Sterilization


[00885554029284]

Moist Heat or Steam Sterilization


[00885554029284]

Moist Heat or Steam Sterilization


[00885554029284]

Moist Heat or Steam Sterilization


[00885554029284]

Moist Heat or Steam Sterilization


[00885554029284]

Moist Heat or Steam Sterilization


[00885554029284]

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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00885556747360 - FASTPAK2024-06-21 FASTPAK TIBIAL BASE TRIAL SIZE 2 LEFT
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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