G7 TYPE 12 / 14 PROVISIONAL HEAD 010002547

GUDID 00880304565210

Biomet Orthopedics, LLC

Femoral head prosthesis trial
Primary Device ID00880304565210
NIH Device Record Key6198bf88-7406-42f7-9bc9-532636751d1a
Commercial Distribution StatusIn Commercial Distribution
Brand NameG7 TYPE 12 / 14 PROVISIONAL HEAD
Version Model Number010002547
Catalog Number010002547
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 Datetrue
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
GS100880304565210 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LZOProsthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00880304565210]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-05-08
Device Publish Date2020-04-30

On-Brand Devices [G7 TYPE 12 / 14 PROVISIONAL HEAD]

00880304565159010002541
00880304565142010002540
00880304565135010002539
00880304565128010002538
00880304565111010002537
00880304565104010002536
00880304565098010002535
00880304565081010002534
00880304565050010002531
00880304565234010002549
00880304565227010002548
00880304565210010002547
00880304565203010002546

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