Large Staple Drill Bit 3.0mm

GUDID M209176620

BIOPRO, INC.

Orthopaedic bone staple, non-adjustable, sterile

• Primary Device ID: M209176620
• NIH Device Record Key: 037e2035-3dc8-4468-9055-1619e2cb1d66
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Large Staple Drill Bit 3.0mm
• Version Model Number: 17662
• 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	M209176620 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K061798

FDA Product Code

• JDR: Staple, Fixation, Bone

Sterilization

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

[M209176620]

Moist Heat or Steam Sterilization

[M209176620]

Moist Heat or Steam Sterilization

[M209176620]

Moist Heat or Steam Sterilization

[M209176620]

Moist Heat or Steam Sterilization

[M209176620]

Moist Heat or Steam Sterilization

[M209176620]

Moist Heat or Steam Sterilization

[M209176620]

Moist Heat or Steam Sterilization

[M209176620]

Moist Heat or Steam Sterilization

[M209176620]

Moist Heat or Steam Sterilization

[M209176620]

Moist Heat or Steam Sterilization

[M209176620]

Moist Heat or Steam Sterilization

[M209176620]

Moist Heat or Steam Sterilization

[M209176620]

Moist Heat or Steam Sterilization

[M209176620]

Moist Heat or Steam Sterilization

[M209176620]

Moist Heat or Steam Sterilization

[M209176620]

Moist Heat or Steam Sterilization

[M209176620]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-05-09
• Device Publish Date: 2019-05-01

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