Guide Screw for Trial Glenosphere 9CCA.13.014

GUDID 08033390113786

Guide Screw for Trial Glenosphere Dia.36 - SMR Shoulder

LIMACORPORATE SPA

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• Primary Device ID: 08033390113786
• NIH Device Record Key: cd2a80b0-7944-41d3-a636-783b92943742
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Guide Screw for Trial Glenosphere
• Version Model Number: Guide Screw
• Catalog Number: 9CCA.13.014
• Company DUNS: 432066322
• Company Name: LIMACORPORATE SPA
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	08033390113786 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K110598

FDA Product Code

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

Sterilization

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

[08033390113786]

Moist Heat or Steam Sterilization

[08033390113786]

Moist Heat or Steam Sterilization

[08033390113786]

Moist Heat or Steam Sterilization

[08033390113786]

Moist Heat or Steam Sterilization

[08033390113786]

Moist Heat or Steam Sterilization

[08033390113786]

Moist Heat or Steam Sterilization

[08033390113786]

Moist Heat or Steam Sterilization

[08033390113786]

Moist Heat or Steam Sterilization

[08033390113786]

Moist Heat or Steam Sterilization

[08033390113786]

Moist Heat or Steam Sterilization

[08033390113786]

Moist Heat or Steam Sterilization

[08033390113786]

Moist Heat or Steam Sterilization

[08033390113786]

Moist Heat or Steam Sterilization

[08033390113786]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2023-05-03
• Device Publish Date: 2016-08-05

On-Brand Devices [Guide Screw for Trial Glenosphere]

• 08033390113793: Guide Screw for Trial Glenosphere Dia.36 S-R - SMR Shoulder
• 08033390113786: Guide Screw for Trial Glenosphere Dia.36 - SMR Shoulder