Drill Guide Single Hole

GUDID M20917560

BIOPRO, INC.

Surgical drill guide, reusable

• Primary Device ID: M20917560
• NIH Device Record Key: 4d5794a2-1fde-4394-a00a-bdc0d9b2a447
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Drill Guide Single Hole
• Version Model Number: 17656
• 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	M20917560 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K061798

FDA Product Code

• FZX: Guide, Surgical, Instrument

Sterilization

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

[M20917560]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-04-06
• Device Publish Date: 2019-05-01

On-Brand Devices [Drill Guide Single Hole]

• M20917560: 17656
• 00810012484220: 19467
• 00810012483858: 17656