Wrench

GUDID M209189290

BIOPRO, INC.

Orthopaedic prosthesis implantation instrument, reusable

• Primary Device ID: M209189290
• NIH Device Record Key: a3639074-a0c3-45c0-b028-14a87b9b2996
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Wrench
• Version Model Number: 18929
• 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	M209189290 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K061089

FDA Product Code

• HXC: Wrench

Sterilization

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

[M209189290]

Moist Heat or Steam Sterilization

[M209189290]

Moist Heat or Steam Sterilization

[M209189290]

Moist Heat or Steam Sterilization

[M209189290]

Moist Heat or Steam Sterilization

[M209189290]

Moist Heat or Steam Sterilization

[M209189290]

Moist Heat or Steam Sterilization

[M209189290]

Moist Heat or Steam Sterilization

[M209189290]

Moist Heat or Steam Sterilization

[M209189290]

Moist Heat or Steam Sterilization

[M209189290]

Moist Heat or Steam Sterilization

[M209189290]

Moist Heat or Steam Sterilization

[M209189290]

Moist Heat or Steam Sterilization

[M209189290]

Moist Heat or Steam Sterilization

[M209189290]

Moist Heat or Steam Sterilization

[M209189290]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-05-14
• Device Publish Date: 2019-05-06

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• M209178080 - THUMB MOD HEAD TITANIUM 15MM: 2024-07-08
• M209178090 - THUMB MOD HEAD TITANIUM 15MM+2: 2024-07-08
• M209177980 - THUMB MOD HEAD TITANIUM 13MM: 2024-06-07