TOE JOINT TITANIUM NPC M/L 21.5MM

GUDID 00810012480109

BIOPRO, INC.

Partial metatarsophalangeal joint prosthesis

• Primary Device ID: 00810012480109
• NIH Device Record Key: dc845a6a-22b5-48c7-9134-d48086f6b290
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TOE JOINT TITANIUM NPC M/L 21.5MM
• Version Model Number: 16815
• 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: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810012480109 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K041595

FDA Product Code

• KWD: Prosthesis, Toe, Hemi-, Phalangeal

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

On-Brand Devices [TOE JOINT TITANIUM NPC M/L 21.5MM]

• 00810012480109: 16815
• M209168150: 16815