Drill Bit Blue 2.0mm 115mm AO

GUDID M209226800

BIOPRO, INC.

Surgical drill guide, single-use

• Primary Device ID: M209226800
• NIH Device Record Key: a15b84fa-c9d9-40e0-8eac-0d31ad4de1ab
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Drill Bit Blue 2.0mm 115mm AO
• Version Model Number: 226780
• 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: 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	M209226800 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162674

FDA Product Code

• HTW: Bit, Drill

Sterilization

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

[M209226800]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-12-25
• Device Publish Date: 2019-12-17

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