MIS CALCANEAL DEPTH GAUGE 110018220

GUDID 00887868131035

Biomet Orthopedics, LLC

Surgical depth gauge, reusable
Primary Device ID00887868131035
NIH Device Record Key96ef6c40-1948-4ea5-bc3c-01d6d0594241
Commercial Distribution StatusIn Commercial Distribution
Brand NameMIS CALCANEAL DEPTH GAUGE
Version Model Number110018220
Catalog Number110018220
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 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 Identifiers

Device Issuing AgencyDevice ID
GS100887868131035 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HRSPlate, fixation, bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00887868131035]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-12-07
Device Publish Date2016-09-26

Devices Manufactured by Biomet Orthopedics, LLC

00887868254451 - Comprehensive® Reverse Shoulder2024-11-21
00887868578250 - Comprehensive®2024-11-13
08428898885684 - BIPASS DISPOSABLE PUSHER2024-09-11
08428898885691 - BIPASS DISPOSABLE PUSHER2024-09-11
00880304338548 - AGC ANTERIOR FILE2024-09-11
00880304339224 - PARALLEL PULLER2024-09-11
00880304342187 - AGC MODULAR TIBIAL II2024-09-11
00880304365247 - BIO-MODULAR2024-09-11

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