HMRS 6465-6-018

GUDID 07613327048216

Bearing

Howmedica Osteonics Corp.

Uncoated hip femur prosthesis, modular
Primary Device ID07613327048216
NIH Device Record Key585cbf69-f490-4361-a5f6-e49ac02cd9f6
Commercial Distribution StatusIn Commercial Distribution
Brand NameHMRS
Version Model Number6465-6-018
Catalog Number6465-6-018
Company DUNS058311945
Company NameHowmedica Osteonics Corp.
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 Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Device Size Text, specify0
Length24 Millimeter
Device Size Text, specify0
Length24 Millimeter
Device Size Text, specify0
Length24 Millimeter
Device Size Text, specify0
Length24 Millimeter
Device Size Text, specify0
Length24 Millimeter
Device Size Text, specify0
Length24 Millimeter
Device Size Text, specify0
Length24 Millimeter
Device Size Text, specify0
Length24 Millimeter
Device Size Text, specify0
Length24 Millimeter
Device Size Text, specify0
Length24 Millimeter
Device Size Text, specify0
Length24 Millimeter
Device Size Text, specify0
Length24 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS107613327048216 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KROPROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

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 Date2015-09-24

On-Brand Devices [HMRS]

07613327049930Axis Pin
07613327048933Wedge
07613327048216Bearing
04546540276520G I-II. CIRCLIPS

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