IMPACTOR HANDLE

GUDID 00810012485715

BIOPRO, INC.

Orthopaedic prosthesis implantation instrument, single-use

• Primary Device ID: 00810012485715
• NIH Device Record Key: 6deaedfb-1987-4a1f-8253-c1be404245f6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IMPACTOR HANDLE
• Version Model Number: 15259
• 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	00810012485715 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K041595

FDA Product Code

• HWA: Impactor

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 [IMPACTOR HANDLE]

• M209152590: 15259
• 00810012485715: 15259