PARALLEL WIRE / DRILL GUIDE 13509

GUDID 00887868001673

Biomet Orthopedics, LLC

Surgical drill guide, reusable
Primary Device ID00887868001673
NIH Device Record Keyf22d2f32-fb2e-438e-b6ee-c80931ddb91c
Commercial Distribution StatusIn Commercial Distribution
Brand NamePARALLEL WIRE / DRILL GUIDE
Version Model Number13509
Catalog Number13509
Company DUNS129278169
Company NameBiomet Orthopedics, LLC
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)348-9500
Emailcustomerservice@zimmerbiomet.com

Device Dimensions

Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS100887868001673 [Primary]

FDA Product Code

HTWBIT, DRILL

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00887868001673]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-11-22
Device Publish Date2017-04-07

Devices Manufactured by Biomet Orthopedics, LLC

00887868004087 - PRIMARY TREPHINE2024-04-03
00887868004094 - BUSHING2024-04-03
00887868004100 - SECONDARY TREPHINE2024-04-03
00887868048272 - TREPHINE2024-04-03
00887868048289 - TREPHINE2024-04-03
00887868048296 - TREPHINE2024-04-03
00887868048302 - TREPHINE2024-04-03
00880304658387 - Compress®2024-03-11

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.