Impactor Tip SM

GUDID M209152560

BIOPRO, INC.

Orthopaedic prosthesis implantation instrument, reusable

• Primary Device ID: M209152560
• NIH Device Record Key: dc9cc35a-44aa-44c3-8ee0-813ff49075cc
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• 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	M209152560 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K041595

FDA Product Code

• HWA: Impactor

Sterilization

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

[M209152560]

Moist Heat or Steam Sterilization

[M209152560]

Moist Heat or Steam Sterilization

[M209152560]

Moist Heat or Steam Sterilization

[M209152560]

Moist Heat or Steam Sterilization

[M209152560]

Moist Heat or Steam Sterilization

[M209152560]

Moist Heat or Steam Sterilization

[M209152560]

Moist Heat or Steam Sterilization

[M209152560]

Moist Heat or Steam Sterilization

[M209152560]

Moist Heat or Steam Sterilization

[M209152560]

Moist Heat or Steam Sterilization

[M209152560]

Moist Heat or Steam Sterilization

[M209152560]

Moist Heat or Steam Sterilization

[M209152560]

Moist Heat or Steam Sterilization

[M209152560]

Moist Heat or Steam Sterilization

[M209152560]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-05-09
• Device Publish Date: 2019-05-01

On-Brand Devices [Impactor Tip SM]

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