14MM FUSION NAIL, RIGHT

GUDID M209215910

BIOPRO, INC.

Arthrodesis nail, non-sterile

• Primary Device ID: M209215910
• NIH Device Record Key: 734d25ca-32cd-4103-8830-5a388828fba8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 14MM FUSION NAIL, RIGHT
• Version Model Number: 21591
• 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
HIBCC	M209215910 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K163627

FDA Product Code

• HSB: Rod, Fixation, Intramedullary And Accessories

Sterilization

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

[M209215910]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-06-20
• Device Publish Date: 2019-06-12

On-Brand Devices [14MM FUSION NAIL, RIGHT ]

• M209215990: 21599
• M209215910: 21591