PE – cup insert 10°

GUDID 04048844006969

implantcast GmbH

Constrained polyethylene acetabular liner
Primary Device ID04048844006969
NIH Device Record Keyf67103c4-0653-4bfe-a5f3-3afb84b9ccda
Commercial Distribution StatusIn Commercial Distribution
Brand NamePE – cup insert 10°
Version Model Number02804552
Company DUNS324369826
Company Nameimplantcast GmbH
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

Device Dimensions

Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS104048844006969 [Primary]

FDA Product Code

LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-10-01
Device Publish Date2018-08-31

On-Brand Devices [PE – cup insert 10°]

0404884435570802803139
0404884400696902804552
0404884400695202804548
0404884400684602803152
0404884400683902803148
0404884400682202803144

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