ProMade Shoulder 9CCS.13.442

GUDID 08033390254847

PRIMA TT Glenoid - Trial Glenosphere Dia. 42 mm

LIMACORPORATE SPA

Reverse shoulder head prosthesis trial

• Primary Device ID: 08033390254847
• NIH Device Record Key: 772f7f6b-d448-4e0d-a7cb-2f4b91b61970
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ProMade Shoulder
• Version Model Number: 9CCS.13.442
• Catalog Number: 9CCS.13.442
• Company DUNS: 432066322
• Company Name: LIMACORPORATE SPA
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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 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	08033390254847 [Primary]

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

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

[08033390254847]

Moist Heat or Steam Sterilization

[08033390254847]

Moist Heat or Steam Sterilization

[08033390254847]

Moist Heat or Steam Sterilization

[08033390254847]

Moist Heat or Steam Sterilization

[08033390254847]

Moist Heat or Steam Sterilization

[08033390254847]

Moist Heat or Steam Sterilization

[08033390254847]

Moist Heat or Steam Sterilization

[08033390254847]

Moist Heat or Steam Sterilization

[08033390254847]

Moist Heat or Steam Sterilization

[08033390254847]

Moist Heat or Steam Sterilization

[08033390254847]

Moist Heat or Steam Sterilization

[08033390254847]

Moist Heat or Steam Sterilization

[08033390254847]

Moist Heat or Steam Sterilization

[08033390254847]

Moist Heat or Steam Sterilization

[08033390254847]

Moist Heat or Steam Sterilization

[08033390254847]

Moist Heat or Steam Sterilization

[08033390254847]

Moist Heat or Steam Sterilization

[08033390254847]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-05-18
• Device Publish Date: 2023-05-10

On-Brand Devices [ProMade Shoulder]

• 08033390254878: PRIMA TT Glenoid - Trial Glenosphere Dia. 42 mm ECC.
• 08033390254861: PRIMA TT Glenoid - Trial Glenosphere Dia. 40 mm ECC.
• 08033390254854: PRIMA TT Glenoid - Trial Glenosphere Dia. 36 mm ECC.
• 08033390254847: PRIMA TT Glenoid - Trial Glenosphere Dia. 42 mm
• 08033390254823: PRIMA TT Glenoid - Trial Glenosphere Dia. 40 mm
• 08033390254793: PRIMA TT Glenoid - Trial Glenosphere Dia. 36 mm
• 08033390282659: ProMade Shoulder - Guide for Long Helix Drill Dia. 3,5 mm
• 08033390282642: ProMade Shoulder - Long Helix Drill Dia. 3,5 mm