Burr Guide 3 Leg 14x12

GUDID M209183100

BIOPRO, INC.

Surgical drill guide, reusable

• Primary Device ID: M209183100
• NIH Device Record Key: c91373f2-1f9c-4273-85ef-bbfa8f0e672d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Burr Guide 3 Leg 14x12
• Version Model Number: 18310
• 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	M209183100 [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

[M209183100]

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 14x12]

• M209183100: 18310
• 00810012484060: 18310