My Shoulder Bone Models

GUDID 07630030861185

MyShoulder Humeral bone model - Left

Medacta International SA

Orthopaedic prosthesis implantation instrument, single-use
Primary Device ID07630030861185
NIH Device Record Key6fa66b47-88d8-4e4d-9504-594f62c69476
Commercial Distribution StatusIn Commercial Distribution
Brand NameMy Shoulder Bone Models
Version Model Number3.9010
Company DUNS488227125
Company NameMedacta International SA
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 Identifiers

Device Issuing AgencyDevice ID
GS107630030861185 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWSProsthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[07630030861185]

Moist Heat or Steam Sterilization


[07630030861185]

Moist Heat or Steam Sterilization


[07630030861185]

Moist Heat or Steam Sterilization


[07630030861185]

Moist Heat or Steam Sterilization


[07630030861185]

Moist Heat or Steam Sterilization


[07630030861185]

Moist Heat or Steam Sterilization


[07630030861185]

Moist Heat or Steam Sterilization


[07630030861185]

Moist Heat or Steam Sterilization


[07630030861185]

Moist Heat or Steam Sterilization


[07630030861185]

Moist Heat or Steam Sterilization


[07630030861185]

Moist Heat or Steam Sterilization


[07630030861185]

Moist Heat or Steam Sterilization


[07630030861185]

Moist Heat or Steam Sterilization


[07630030861185]

Moist Heat or Steam Sterilization


[07630030861185]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-02-06
Device Publish Date2020-01-29

On-Brand Devices [My Shoulder Bone Models]

07630030861673MyShoulder Glenoidal bone model - Right
07630030861666MyShoulder Humeral bone model - Right
07630030861192MyShoulder Glenoidal bone model - Left
07630030861185MyShoulder Humeral bone model - Left

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