IMPACTOR TIP SM

GUDID 00810012485463

BIOPRO, INC.

Orthopaedic prosthesis implantation instrument, single-use

• Primary Device ID: 00810012485463
• NIH Device Record Key: 2c78061e-c9e9-4200-9100-3a68a725adbc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IMPACTOR TIP SM
• Version Model Number: 15256
• 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	00810012485463 [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 TIP SM]

• M209182840: 18284
• M209152560: 15256
• 00810012485463: 15256