HBS SCREW 3.0 X 12MM SDST

GUDID 00810012484855

BIOPRO, INC.

Orthopaedic bone screw, non-bioabsorbable, sterile

• Primary Device ID: 00810012484855
• NIH Device Record Key: c808c0b8-03b8-40d7-ab82-fd7c2f5c9995
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HBS SCREW 3.0 X 12MM SDST
• Version Model Number: 20517
• 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	00810012484855 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K101030

FDA Product Code

• HWC: Screw, Fixation, Bone

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: 2019-06-13
• Device Publish Date: 2019-06-05

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