SM staple 4 3/4 Bulldog Hemostat

GUDID M20917651

BIOPRO, INC.

Orthopaedic prosthesis implantation instrument, reusable

• Primary Device ID: M20917651
• NIH Device Record Key: 69187cf2-3787-432e-8b75-1a669b1df758
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SM staple 4 3/4 Bulldog Hemostat
• Version Model Number: 17651
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M20917651 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K061798

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

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

[M20917651]

Moist Heat or Steam Sterilization

[M20917651]

Moist Heat or Steam Sterilization

[M20917651]

Moist Heat or Steam Sterilization

[M20917651]

Moist Heat or Steam Sterilization

[M20917651]

Moist Heat or Steam Sterilization

[M20917651]

Moist Heat or Steam Sterilization

[M20917651]

Moist Heat or Steam Sterilization

[M20917651]

Moist Heat or Steam Sterilization

[M20917651]

Moist Heat or Steam Sterilization

[M20917651]

Moist Heat or Steam Sterilization

[M20917651]

Moist Heat or Steam Sterilization

[M20917651]

Moist Heat or Steam Sterilization

[M20917651]

Moist Heat or Steam Sterilization

[M20917651]

Moist Heat or Steam Sterilization

[M20917651]

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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