N/A 21-8014

GUDID 00817470010671

TIBIAL DRILL GUIDE ARM

Smith & Nephew, Inc.

Surgical drill guide, reusable
Primary Device ID00817470010671
NIH Device Record Keyc61ef933-c67d-4059-8165-4f74ee59677c
Commercial Distribution StatusIn Commercial Distribution
Brand NameN/A
Version Model Number21-8014
Catalog Number21-8014
Company DUNS109903521
Company NameSmith & Nephew, Inc.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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)821-5700
Emailgudid@smith-nephew.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100817470010671 [Primary]

FDA Product Code

HXYBRACE, DRILL

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00817470010671]

Moist Heat or Steam Sterilization

[00817470010671]

Moist Heat or Steam Sterilization

[00817470010671]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-01-31
Device Publish Date2015-08-30

On-Brand Devices [N/A]

20817470011634PASSING PIN W DRILL TIP 425MM(17IN)X2.4MM
00817470011401FINAL ASSY HANDSWITCH ARTHROCARE SRVC
00817470011326FINAL ASSEMBLY POWER CORD DOMESTIC SRVC
00817470011296FINAL ASSEMBLY POWER CORD INTL SRVC
20817470011252TOURNIQUET LIMB DRAPE-SMALL
20817470011245TOURNIQUET LIMB DRAPE
00817470011166ANATOMIC ACL STERILIZATION TRAY
008174700111592.8MM PATHFINDER
008174700111421.8MM PATHFINDER
00817470011135TIBIAL BUTTON IMPACTOR
00817470011128TIBIAL DILATOR
008174700111116.5MM TIBIAL DRILL
008174700110987.0 - 8.5 TIBIAL PIN GUIDE BODY
00817470011081KNOT PUSHER
0081747001107440MM PEEK TIBIAL IMPLANT
00817470011067REUSABLE BONE PUNCH 2.8MM Q-FIX IMPLANT
00817470011050DISPOSABLE KIT 2.8MM SHOULDER Q-FIX
00817470011036DISPOSABLE KIT FOR 1.8MM SHOULDER Q-FIX
008174700110292.8MM Q-FIX ALL SUTURE ANCHOR
008174700110121.8MM Q-FIX ALL SUTURE ANCHOR
0081747001100533MM PEEK TIBIAL IMPLANT
00817470010992N8TIVE ACL FEMORAL IMPLANT
00817470010985ACL DISPOSABLE KIT
00817470010930DEPTH GAGE
00817470010923FEMORAL FOOTPRINT TEMPLATE
00817470010916TIBIAL TAMP- SIZE 10.0
00817470010909TIBIAL TAMP- SIZE 9.5
00817470010893TIBIAL TAMP- SIZE 9.0
00817470010886TIBIAL TAMP- SIZE 8.5
00817470010879TIBIAL TAMP- SIZE 8.0
00817470010862TIBIAL TAMP- SIZE 7.5
00817470010855TIBIAL TAMP- SIZE 7.0
00817470010848TAMP EXTENDER
00817470010831SLOTTED MALLET
00817470010824FEMORAL TAMP SIZE 10.0
00817470010817FEMORAL TAMP SIZE 9.5
00817470010800FEMORAL TAMP SIZE 9.0
00817470010794FEMORAL TAMP SIZE 8.5
00817470010787FEMORAL TAMP SIZE 8.0
00817470010770FEMORAL TAMP SIZE 7.5
00817470010763FEMORAL TAMP SIZE 7.0
00817470010749TIBIAL SPACER INSERTER
00817470010732IMPLANT EXTRACTOR
00817470010725CURETTE
00817470010718CLOSED TENDON HARVESTER
00817470010701SLOTTED TENDON HARVESTER
00817470010695GRAFT SIZING BLOCK
00817470010688TUNNEL RASP
00817470010671TIBIAL DRILL GUIDE ARM
00817470010664TIBIAL PIN GUIDE
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