Coronary Artery Probe 3.00mm Long

GUDID B040CPH300L1

Reusable Probe for Coronary Arteries Assorted sizes 1mm to 3mm as indicated by its part number 191mm Length

GENESEE BIOMEDICAL, INC.

Vascular dilator, reusable

• Primary Device ID: B040CPH300L1
• NIH Device Record Key: b8ae7a6b-fb61-4573-93f9-d76f6bbd6961
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Coronary Artery Probe 3.00mm Long
• Version Model Number: CPH-3.00L
• 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	B040CPH300L0 [Primary]
HIBCC	B040CPH300L1 [Package]; Contains: B040CPH300L0; Package: [1 Units]; In Commercial Distribution

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

[B040CPH300L1]

Moist Heat or Steam Sterilization

[B040CPH300L1]

Moist Heat or Steam Sterilization

[B040CPH300L1]

Moist Heat or Steam Sterilization

[B040CPH300L1]

Moist Heat or Steam Sterilization

[B040CPH300L1]

Moist Heat or Steam Sterilization

[B040CPH300L1]

Moist Heat or Steam Sterilization

[B040CPH300L1]

Moist Heat or Steam Sterilization

[B040CPH300L1]

Moist Heat or Steam Sterilization

[B040CPH300L1]

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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