G7 TYPE 12 / 14 PROVISIONAL HEAD 010002548

GUDID 00880304565227

Biomet Orthopedics, LLC

Femoral head prosthesis trial
Primary Device ID00880304565227
NIH Device Record Key54dc7e3e-b0b0-4e50-9521-25549c08f4e9
Commercial Distribution StatusIn Commercial Distribution
Brand NameG7 TYPE 12 / 14 PROVISIONAL HEAD
Version Model Number010002548
Catalog Number010002548
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
GS100880304565227 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OQIHip, semi-constrained, cemented, metal/ceramic/polymer + additive, porous uncemented

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00880304565227]

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

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