Coronary Artery Probe 2.00mm

GUDID B040CPH200

Reusable Probe for Coronary Arteries Assorted sizes 1mm to 3mm as indicated by its part number 140mm Length

GENESEE BIOMEDICAL, INC.

Vascular dilator, reusable

• Primary Device ID: B040CPH200
• NIH Device Record Key: 86b8516d-26d2-4dd1-becb-058e602eb373
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Coronary Artery Probe 2.00mm
• Version Model Number: CPH-2.00
• Company DUNS: 939872651
• Company Name: GENESEE BIOMEDICAL, 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: 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	B040CPH200 [Package]; Contains: B040CPH2000; Package: [1 Units]; In Commercial Distribution
HIBCC	B040CPH2000 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K901531

FDA Product Code

• DWS: Instruments, Surgical, Cardiovascular

Sterilization

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

[B040CPH200]

Moist Heat or Steam Sterilization

[B040CPH200]

Moist Heat or Steam Sterilization

[B040CPH200]

Moist Heat or Steam Sterilization

[B040CPH200]

Moist Heat or Steam Sterilization

[B040CPH200]

Moist Heat or Steam Sterilization

[B040CPH200]

Moist Heat or Steam Sterilization

[B040CPH200]

Moist Heat or Steam Sterilization

[B040CPH200]

Moist Heat or Steam Sterilization

[B040CPH200]

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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