SMR Resurfacing System 9013.17.010

GUDID 08033390038416

Trial Stem Dia.11mm

LIMACORPORATE SPA

Humeral stem prosthesis trial, reusable

• Primary Device ID: 08033390038416
• NIH Device Record Key: 8b3426d6-e4cb-473e-b0a7-2479ddf39b5b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SMR Resurfacing System
• Version Model Number: Trial Stem
• Catalog Number: 9013.17.010
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	08033390038416 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K112900

FDA Product Code

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

Sterilization

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

[08033390038416]

Moist Heat or Steam Sterilization

[08033390038416]

Moist Heat or Steam Sterilization

[08033390038416]

Moist Heat or Steam Sterilization

[08033390038416]

Moist Heat or Steam Sterilization

[08033390038416]

Moist Heat or Steam Sterilization

[08033390038416]

Moist Heat or Steam Sterilization

[08033390038416]

Moist Heat or Steam Sterilization

[08033390038416]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2022-07-04
• Device Publish Date: 2016-04-05

On-Brand Devices [SMR Resurfacing System]

• 08033390038423: Trial Stem Dia.13mm
• 08033390038416: Trial Stem Dia.11mm
• 08033390038621: K. Wire Guide