TEMA Elbow System 9CC0.95.087

GUDID 08033390151269

Flexible Reamer # 4

LIMACORPORATE SPA

Medullary canal orthopaedic reamer, flexible

• Primary Device ID: 08033390151269
• NIH Device Record Key: 183466ef-ae41-4a54-8a3a-7106e00f6a99
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TEMA Elbow System
• Version Model Number: 9CC0.95.087
• Catalog Number: 9CC0.95.087
• 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 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 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	08033390151269 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181362

FDA Product Code

• JDB: Prosthesis, Elbow, Semi-Constrained, Cemented

Sterilization

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

[08033390151269]

Moist Heat or Steam Sterilization

[08033390151269]

Moist Heat or Steam Sterilization

[08033390151269]

Moist Heat or Steam Sterilization

[08033390151269]

Moist Heat or Steam Sterilization

[08033390151269]

Moist Heat or Steam Sterilization

[08033390151269]

Moist Heat or Steam Sterilization

[08033390151269]

Moist Heat or Steam Sterilization

[08033390151269]

Moist Heat or Steam Sterilization

[08033390151269]

Moist Heat or Steam Sterilization

[08033390151269]

Moist Heat or Steam Sterilization

[08033390151269]

Moist Heat or Steam Sterilization

[08033390151269]

Moist Heat or Steam Sterilization

[08033390151269]

Moist Heat or Steam Sterilization

[08033390151269]

Moist Heat or Steam Sterilization

[08033390151269]

Moist Heat or Steam Sterilization

[08033390151269]

Moist Heat or Steam Sterilization

[08033390151269]

Moist Heat or Steam Sterilization

[08033390151269]

Moist Heat or Steam Sterilization

[08033390151269]

Moist Heat or Steam Sterilization

[08033390151269]

Moist Heat or Steam Sterilization

[08033390151269]

Moist Heat or Steam Sterilization

[08033390151269]

Moist Heat or Steam Sterilization

[08033390151269]

Moist Heat or Steam Sterilization

[08033390151269]

Moist Heat or Steam Sterilization

[08033390151269]

Moist Heat or Steam Sterilization

[08033390151269]

Moist Heat or Steam Sterilization

[08033390151269]

Moist Heat or Steam Sterilization

[08033390151269]

Moist Heat or Steam Sterilization

[08033390151269]

Moist Heat or Steam Sterilization

[08033390151269]

Moist Heat or Steam Sterilization

[08033390151269]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-12-06
• Device Publish Date: 2021-11-27

On-Brand Devices [TEMA Elbow System ]

• 08033390151320: Flexible Reamer # 10
• 08033390151313: Flexible Reamer # 9
• 08033390151306: Flexible Reamer # 8
• 08033390151290: Flexible Reamer # 7
• 08033390151283: Flexible Reamer # 6
• 08033390151276: Flexible Reamer # 5
• 08033390151269: Flexible Reamer # 4
• 08033390151252: Flexible Reamer # 3
• 08033390195225: Flexible Reamer # 3