ProMade 9CC0.13.03E

GUDID 08033390237420

M8 Long Handle

LIMACORPORATE SPA

Orthopaedic prosthesis implantation instrument, reusable

• Primary Device ID: 08033390237420
• NIH Device Record Key: 89c51732-946e-4cfe-97f0-f33a374405bc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ProMade
• Version Model Number: 9CC0.13.03E
• Catalog Number: 9CC0.13.03E
• 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	08033390237420 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K100858

FDA Product Code

• KWT: Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented

Sterilization

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

[08033390237420]

Moist Heat or Steam Sterilization

[08033390237420]

Moist Heat or Steam Sterilization

[08033390237420]

Moist Heat or Steam Sterilization

[08033390237420]

Moist Heat or Steam Sterilization

[08033390237420]

Moist Heat or Steam Sterilization

[08033390237420]

Moist Heat or Steam Sterilization

[08033390237420]

Moist Heat or Steam Sterilization

[08033390237420]

Moist Heat or Steam Sterilization

[08033390237420]

Moist Heat or Steam Sterilization

[08033390237420]

Moist Heat or Steam Sterilization

[08033390237420]

Moist Heat or Steam Sterilization

[08033390237420]

Moist Heat or Steam Sterilization

[08033390237420]

Moist Heat or Steam Sterilization

[08033390237420]

Moist Heat or Steam Sterilization

[08033390237420]

Moist Heat or Steam Sterilization

[08033390237420]

Moist Heat or Steam Sterilization

[08033390237420]

Moist Heat or Steam Sterilization

[08033390237420]

Moist Heat or Steam Sterilization

[08033390237420]

Moist Heat or Steam Sterilization

[08033390237420]

Moist Heat or Steam Sterilization

[08033390237420]

Moist Heat or Steam Sterilization

[08033390237420]

Moist Heat or Steam Sterilization

[08033390237420]

Moist Heat or Steam Sterilization

[08033390237420]

Moist Heat or Steam Sterilization

[08033390237420]

Moist Heat or Steam Sterilization

[08033390237420]

Moist Heat or Steam Sterilization

[08033390237420]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-09-29
• Device Publish Date: 2022-09-21

On-Brand Devices [ProMade]

• 08033390132664: Long Stem for Glenosphere Extractor
• 08033390116657: Cannulated Handle with Flange
• 08033390237338: Glenoid Drilling Guide - Dia. 3.2 mm Drill
• 08033390237420: M8 Long Handle
• 08033390237413: M6 Handle with Flange
• 08033390237406: M8 Handle with Flange
• 08033390244640: Glenoid Drilling Guide Dia. 2,7 mm
• 08033390271318: ProMade - PRIMA TT Glenoid Glenosphere Positioner