THUMB MOD HEAD TITANIUM 12MM+4

GUDID M209202340

BIOPRO, INC.

Carpometacarpal interpositional spacer, non-bioabsorbable

• Primary Device ID: M209202340
• NIH Device Record Key: 4bd5831e-ca55-4eee-8bfe-5cee5c12a1bf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: THUMB MOD HEAD TITANIUM 12MM+4
• Version Model Number: 20234
• 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: true
• Lot Batch: true
• Serial Number: true
• 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	M209202340 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K061089

FDA Product Code

• KYI: Prosthesis, Wrist, Carpal Trapezium

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2023-04-04
• Device Publish Date: 2015-09-16

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