Sizing Guide 12MM

GUDID M209198060

BIOPRO, INC.

Orthopaedic prosthesis implantation instrument, reusable

• Primary Device ID: M209198060
• NIH Device Record Key: 456fe01c-a94c-400c-8eec-53631e1c7a43
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sizing Guide 12MM
• Version Model Number: 19806
• Company DUNS: 618749857
• Company Name: BIOPRO, INC.
• 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: true
• Expiration Date: true
• 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
HIBCC	M209198060 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K061089

FDA Product Code

• HWT: Template

Sterilization

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

[M209198060]

Moist Heat or Steam Sterilization

[M209198060]

Moist Heat or Steam Sterilization

[M209198060]

Moist Heat or Steam Sterilization

[M209198060]

Moist Heat or Steam Sterilization

[M209198060]

Moist Heat or Steam Sterilization

[M209198060]

Moist Heat or Steam Sterilization

[M209198060]

Moist Heat or Steam Sterilization

[M209198060]

Moist Heat or Steam Sterilization

[M209198060]

Moist Heat or Steam Sterilization

[M209198060]

Moist Heat or Steam Sterilization

[M209198060]

Moist Heat or Steam Sterilization

[M209198060]

Moist Heat or Steam Sterilization

[M209198060]

Moist Heat or Steam Sterilization

[M209198060]

Moist Heat or Steam Sterilization

[M209198060]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-05-14
• Device Publish Date: 2019-05-06

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• M209177980 - THUMB MOD HEAD TITANIUM 13MM: 2024-06-07