BURR GUIDE 3 LEG 18X16

GUDID 00810012484053

BIOPRO, INC.

Surgical drill guide, single-use

• Primary Device ID: 00810012484053
• NIH Device Record Key: a9bf64ab-66c2-446b-82a0-b8f991d2d84e
• 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: 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	00810012484053 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K072298

FDA Product Code

• FZX: Guide, Surgical, Instrument

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-08-09
• Device Publish Date: 2019-06-06

On-Brand Devices [BURR GUIDE 3 LEG 18X16]

• M209183090: 18309
• 00810012484053: 18309