Robotic Tool Kit Valve Sizer Stainless

GUDID B040RTKVSS1

Stainless Steel Valve Sizers Reusable

GENESEE BIOMEDICAL, INC.

Heart valve annulus sizer, reusable

• Primary Device ID: B040RTKVSS1
• NIH Device Record Key: 8bfbc5b7-c538-4175-b509-863ce1ce1764
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Robotic Tool Kit Valve Sizer Stainless
• Version Model Number: RTK-VSS
• Company DUNS: 939872651
• Company Name: GENESEE BIOMEDICAL, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B040RTKVSS0 [Primary]
HIBCC	B040RTKVSS1 [Package]; Contains: B040RTKVSS0; Package: [1 Units]; In Commercial Distribution

FDA Product Code

• DTI: Sizer, Heart-Valve, Prosthesis

Sterilization

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

[B040RTKVSS1]

Moist Heat or Steam Sterilization

[B040RTKVSS1]

Moist Heat or Steam Sterilization

[B040RTKVSS1]

Moist Heat or Steam Sterilization

[B040RTKVSS1]

Moist Heat or Steam Sterilization

[B040RTKVSS1]

Moist Heat or Steam Sterilization

[B040RTKVSS1]

Moist Heat or Steam Sterilization

[B040RTKVSS1]

Moist Heat or Steam Sterilization

[B040RTKVSS1]

Moist Heat or Steam Sterilization

[B040RTKVSS1]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-12-13
• Device Publish Date: 2024-12-05

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