MODULAR HIP SYSTEM CP153770

GUDID 00880304045958

Biomet Orthopedics, LLC

Non-constrained polyethylene acetabular liner
Primary Device ID00880304045958
NIH Device Record Key5d5c30d4-02a5-4590-ab8d-1818b49e864a
Commercial Distribution StatusIn Commercial Distribution
Brand NameMODULAR HIP SYSTEM
Version Model NumberCP153770
Catalog NumberCP153770
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

Device Dimensions

Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS100880304045958 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LPHPROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-05-30
Device Publish Date2015-10-24

On-Brand Devices [MODULAR HIP SYSTEM]

00880304211087112000
00880304053052CP155338
00880304053045CP155337
00880304053021CP155335
00880304045958CP153770
00880304044586CP153371
00880304044494CP153298

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