MRS 6487-6-076

GUDID 07613327049077

Humeral Intercalary Stem

Howmedica Osteonics Corp.

Uncoated shoulder humeral stem prosthesis
Primary Device ID07613327049077
NIH Device Record Key10d7958a-6624-4228-a62b-dfd5275e0146
Commercial Distribution StatusIn Commercial Distribution
Brand NameMRS
Version Model Number6487-6-076
Catalog Number6487-6-076
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
Length50 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS107613327049077 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HSDPROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED

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 [MRS]

07613327141337Assembly Screw
07613327049817Femoral Intercalary Stem
07613327049794Tibial Module Stem Section
07613327049787Curved Cemented Stem
07613327049770Femoral Intercalary Stem
07613327049763Humeral Module
07613327049756Humeral Module
07613327049749Humeral Module
07613327049732Humeral Module
07613327049725Humeral Module
07613327049718Humeral Module
07613327049374Straight Cemented Stem
07613327049367Straight Cemented Stem
07613327049183Humeral Intercalary Stem
07613327049138Humeral Proximal Cap
07613327049114Humeral Intercalary Stem
07613327049107Humeral Intercalary Stem
07613327049091Humeral Intercalary Stem
07613327049084Humeral Intercalary Stem
07613327049077Humeral Intercalary Stem
07613327049060Humeral Module
07613327049053Humeral Intercalary Stem
07613327049046Humeral Module
07613327049039Humeral Module
07613327049022Humeral Module
07613327049015Humeral Module
07613327049008Humeral Module
07613327048995Humeral Module
07613327048988Humeral Module
07613327048971Humeral Module
07613327048964Humeral Module
07613327048957Humeral Module
07613327048940Humeral Module
07613327048742Humeral Intercalary Stem
07613327048698Pediatric Tibial Bearing Component
07613327048681Humeral Module
07613327048674Tibial Module Stem Section
07613327048667Humeral Module
07613327048650Tibial Module Stem Section
07613327048643Tibial Module Stem Section
07613327048636Tibial Module Stem Section
07613327048629Tibial Module Stem Section
07613327048612Curved Cemented Stem
07613327048605Curved Cemented Stem
07613327048599Curved Cemented Stem
07613327048582Curved Cemented Stem
07613327048575Curved Cemented Stem
07613327048568Curved Cemented Stem
07613327048551Long Curved Cemented Stem
07613327048544Curved Cemented Stem

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