SMR Resurfacing System 9013.27.200

GUDID 08033390038621

K. Wire Guide

LIMACORPORATE SPA

Orthopaedic prosthesis implantation positioning instrument, reusable

• Primary Device ID: 08033390038621
• NIH Device Record Key: e45661c6-7382-470a-b730-ffd5440ac786
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SMR Resurfacing System
• Version Model Number: K. Wire Guide
• Catalog Number: 9013.27.200
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	08033390038621 [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

[08033390038621]

Moist Heat or Steam Sterilization

[08033390038621]

Moist Heat or Steam Sterilization

[08033390038621]

Moist Heat or Steam Sterilization

[08033390038621]

Moist Heat or Steam Sterilization

[08033390038621]

Moist Heat or Steam Sterilization

[08033390038621]

Moist Heat or Steam Sterilization

[08033390038621]

Moist Heat or Steam Sterilization

[08033390038621]

Moist Heat or Steam Sterilization

[08033390038621]

Moist Heat or Steam Sterilization

[08033390038621]

Moist Heat or Steam Sterilization

[08033390038621]

Moist Heat or Steam Sterilization

[08033390038621]

Moist Heat or Steam Sterilization

[08033390038621]

Moist Heat or Steam Sterilization

[08033390038621]

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: 2016-04-05

On-Brand Devices [SMR Resurfacing System]

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