.062" DIA X 8" LONG 24415

GUDID 00880304520547

Biomet Orthopedics, LLC

Bone nail guidewire, reusable Surgical drill guide, reusable
Primary Device ID00880304520547
NIH Device Record Key88897daf-1cef-4b8a-9b80-478cc3953333
Commercial Distribution StatusIn Commercial Distribution
Brand Name.062" DIA X 8" LONG
Version Model Number24415
Catalog Number24415
Company DUNS129278169
Company NameBiomet Orthopedics, LLC
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
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
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS100880304520547 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HTYPIN, FIXATION, SMOOTH

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-10-05
Device Publish Date2016-09-23

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.