My Shoulder guide

GUDID 07630030861659

MyShoulder Glenoidal reaming guide - Right

Medacta International SA

Orthopaedic prosthesis implantation instrument, single-use

• Primary Device ID: 07630030861659
• NIH Device Record Key: f5462038-c7c4-4224-9e2d-2c95dd7e4b49
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: My Shoulder guide
• Version Model Number: 3.1004
• Company DUNS: 488227125
• Company Name: Medacta International SA
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07630030861659 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190738

FDA Product Code

• KWS: Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[07630030861659]

Moist Heat or Steam Sterilization

[07630030861659]

Moist Heat or Steam Sterilization

[07630030861659]

Moist Heat or Steam Sterilization

[07630030861659]

Moist Heat or Steam Sterilization

[07630030861659]

Moist Heat or Steam Sterilization

[07630030861659]

Moist Heat or Steam Sterilization

[07630030861659]

Moist Heat or Steam Sterilization

[07630030861659]

Moist Heat or Steam Sterilization

[07630030861659]

Moist Heat or Steam Sterilization

[07630030861659]

Moist Heat or Steam Sterilization

[07630030861659]

Moist Heat or Steam Sterilization

[07630030861659]

Moist Heat or Steam Sterilization

[07630030861659]

Moist Heat or Steam Sterilization

[07630030861659]

Moist Heat or Steam Sterilization

[07630030861659]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-02-06
• Device Publish Date: 2020-01-29

On-Brand Devices [My Shoulder guide]

• 07630030861659: MyShoulder Glenoidal reaming guide - Right
• 07630030861642: MyShoulder Humeral cutting guide - Right
• 07630030861178: MyShoulder Humeral cutting guide - Left
• 07630030861161: MyShoulder Glenoidal reaming guide - Left