TEMPLATE 8.00MM/8.75MM

GUDID 00810012485579

BIOPRO, INC.

Orthopaedic prosthesis implantation instrument, single-use

• Primary Device ID: 00810012485579
• NIH Device Record Key: e1b8eb5b-a429-4c6e-a4bf-40b32b6d67cb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TEMPLATE 8.00MM/8.75MM
• Version Model Number: 16972
• 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: false
• Manufacturing Date: true
• 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	00810012485579 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K041595

FDA Product Code

• HWT: Template

Sterilization

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

Device Entry Metadata

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

Devices Manufactured by BIOPRO, INC.

• M209177990 - THUMB MOD HEAD TITANIUM 13MM+2: 2024-07-08
• M209178000 - THUMB MOD HEAD TITANIIUM 12MM: 2024-07-08
• M209178010 - THUMB MOD HEAD TITANIUM 12MM+2: 2024-07-08
• M209178060 - THUMB MOD HEAD TITANIUM 14MM: 2024-07-08
• M209178070 - THUMB MOD HEAD TITANIUM 14MM+2: 2024-07-08
• M209178080 - THUMB MOD HEAD TITANIUM 15MM: 2024-07-08
• M209178090 - THUMB MOD HEAD TITANIUM 15MM+2: 2024-07-08
• M209177980 - THUMB MOD HEAD TITANIUM 13MM: 2024-06-07