SMR 9013.22.201

GUDID 08033390240048

SMR - Modular head pusher for press

LIMACORPORATE SPA

Orthopaedic prosthesis implantation positioning instrument, reusable

• Primary Device ID: 08033390240048
• NIH Device Record Key: d447bb5b-152e-4bb6-bf4b-b29ce972fc59
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SMR
• Version Model Number: 9013.22.201
• Catalog Number: 9013.22.201
• 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	08033390240048 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K100858

FDA Product Code

• HSD: Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented

Sterilization

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

[08033390240048]

Moist Heat or Steam Sterilization

[08033390240048]

Moist Heat or Steam Sterilization

[08033390240048]

Moist Heat or Steam Sterilization

[08033390240048]

Moist Heat or Steam Sterilization

[08033390240048]

Moist Heat or Steam Sterilization

[08033390240048]

Moist Heat or Steam Sterilization

[08033390240048]

Moist Heat or Steam Sterilization

[08033390240048]

Moist Heat or Steam Sterilization

[08033390240048]

Moist Heat or Steam Sterilization

[08033390240048]

Moist Heat or Steam Sterilization

[08033390240048]

Moist Heat or Steam Sterilization

[08033390240048]

Moist Heat or Steam Sterilization

[08033390240048]

Moist Heat or Steam Sterilization

[08033390240048]

Moist Heat or Steam Sterilization

[08033390240048]

Moist Heat or Steam Sterilization

[08033390240048]

Moist Heat or Steam Sterilization

[08033390240048]

Moist Heat or Steam Sterilization

[08033390240048]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-11-03
• Device Publish Date: 2023-10-26

On-Brand Devices [SMR]

• 08033390111263: SMR : HEMISPHERICAL HUMERAL REAMER Ø54mm
• 08033390111256: SMR : HEMISPHERICAL HUMERAL REAMER Ø50mm
• 08033390111249: SMR : HEMISPHERICAL HUMERAL REAMER Ø46mm
• 08033390111232: SMR : HEMISPHERICAL HUMERAL REAMER Ø42mm
• 08033390240055: SMR - Modular head plate for press
• 08033390240048: SMR - Modular head pusher for press