Burr Guide 3 Leg 18x16

GUDID M209183090

BIOPRO, INC.

Surgical drill guide, reusable

• Primary Device ID: M209183090
• NIH Device Record Key: 564f5acc-a6e9-4f14-af1b-2588964de8ff
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Burr Guide 3 Leg 18x16
• Version Model Number: 18309
• 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	M209183090 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K072298

FDA Product Code

• FZX: Guide, Surgical, Instrument

Sterilization

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

[M209183090]

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 [Burr Guide 3 Leg 18x16]

• M209183090: 18309
• 00810012484053: 18309