Active Articulation 010000991

GUDID 00880304527393

Biomet Orthopedics, LLC

Non-constrained polyethylene acetabular liner Non-constrained polyethylene acetabular liner Non-constrained polyethylene acetabular liner
Primary Device ID00880304527393
NIH Device Record Key59b65251-97fc-4d6e-87a2-1288a7aef422
Commercial Distribution StatusIn Commercial Distribution
Brand NameActive Articulation
Version Model Number010000991
Catalog Number010000991
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
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS100880304527393 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWYProsthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-05-25
Device Publish Date2020-05-15

On-Brand Devices [Active Articulation]

00880304527416010000993
00880304527409010000992
00880304520042592806
00880304527393010000991
00880304527386010000990

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