Round Carbide Burr 5.0MM

GUDID M209182770

BIOPRO, INC.

Podiatric bur, reusable

• Primary Device ID: M209182770
• NIH Device Record Key: bba006cd-eec3-4f43-8850-eda9deb32932
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Round Carbide Burr 5.0MM
• Version Model Number: 18277
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M209182770 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K061089

FDA Product Code

• HTT: Burr, Orthopedic

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-05-13
• Device Publish Date: 2019-05-03

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