IMPACT RIMLOC HIP SYSTEM 12-112028

GUDID 00880304221093

Biomet Orthopedics, LLC

Non-constrained polyethylene acetabular liner
Primary Device ID00880304221093
NIH Device Record Key03afd8a7-9dcb-41d0-88d3-519cbf5768f3
Commercial Distribution StatusIn Commercial Distribution
Brand NameIMPACT RIMLOC HIP SYSTEM
Version Model Number12-112028
Catalog Number12-112028
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
GS100880304221093 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MEHProsthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-10-24

On-Brand Devices [IMPACT RIMLOC HIP SYSTEM]

0088030422109312-112028
0088030422108612-112027
0088030422107912-112026
0088030422106212-112025
0088030422105512-112024
0088030422104812-112023
0088030422103112-112022

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