Restoration ADM/MDM X3 Insert 7236-2-860

GUDID 07613327315851

Restoration ADM/MDM X3 Insert

Howmedica Osteonics Corp.

Non-constrained polyethylene acetabular liner
Primary Device ID07613327315851
NIH Device Record Key3858ef9e-fd21-4f7e-8d6b-1487539338c4
Commercial Distribution StatusIn Commercial Distribution
Brand NameRestoration ADM/MDM X3 Insert
Version Model Number7236-2-860
Catalog Number7236-2-860
Company DUNS058311945
Company NameHowmedica Osteonics Corp.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Lumen/Inner Diameter28 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS107613327315851 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LWJProsthesis, hip, semi-constrained, metal/polymer, uncemented

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-11-20
Device Publish Date2019-11-12

On-Brand Devices [Restoration ADM/MDM X3 Insert]

07613327315998Restoration ADM/MDM X3 Insert
07613327315974Restoration ADM/MDM X3 Insert
07613327315967Restoration ADM/MDM X3 Insert
07613327315851Restoration ADM/MDM X3 Insert
07613327315820Restoration ADM/MDM X3 Insert
07613327315813Restoration ADM/MDM X3 Insert

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