Identity
- Trade Name
- Coronary Artery Probe 2.00mm FDA UDI
- Generic Name
- Vascular dilator, reusable FDA UDI
- Device Name
- Reusable Probe for Coronary Arteries Assorted sizes 1mm to 3mm as indicated by its part number 140mm Length FDA UDI
- Model / Reference
- CPH-2.00 FDA UDI
- Description
- Reusable Probe for Coronary Arteries Assorted sizes 1mm to 3mm as indicated by its part number 140mm Length FDA UDI
Identifiers
- Primary DI / UDI-DI
- B040CPH2000 FDA UDI
- 510(k) Number
- K901531 FDA UDI
- FDA Product Code
- DWS FDA UDI
- GMDN Term
- Vascular dilator, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 870.4500 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Vascular dilator, reusable
Coronary Artery Probe 2.00mm by Genesee Biomedical, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Vascular dilator, reusable.
- Marina Medical — MARINA MEDICAL INSTRUMENTS, INC. · Class I
- Novo Surgical — NOVO SURGICAL, INC. · Class II
- Novo Surgical Inc. — NOVO SURGICAL, INC. · Class I
- RZ Medizintechnik GmbH — RZ-Medizintechnik GmbH · Class I
- Millennium — AVALIGN TECHNOLOGIES, Inc. · Class II
- Marina Medical — MARINA MEDICAL INSTRUMENTS, INC. · Class I
- HNM MEDICAL — HNM STAINLESS, LLC. · Class I
- Marina Medical — MARINA MEDICAL INSTRUMENTS, INC. · Class I
Cleared under the same submission
K901531 also covers:
- Coronary Artery Probe 1.00mm Long — GENESEE BIOMEDICAL, INC.
- Coronary Artery Probe 1.25mm — GENESEE BIOMEDICAL, INC.
- Coronary Artery Probe 1.25mm Long — GENESEE BIOMEDICAL, INC.
- Coronary Artery Probe 1.50mm — GENESEE BIOMEDICAL, INC.
- Coronary Artery Probe 1.50mm Long — GENESEE BIOMEDICAL, INC.
- Coronary Artery Probe 1.75mm — GENESEE BIOMEDICAL, INC.
- Coronary Artery Probe 1.75mm Long — GENESEE BIOMEDICAL, INC.
- Coronary Artery Probe 1mm — GENESEE BIOMEDICAL, INC.
- Coronary Artery Probe 2.00mm Long — GENESEE BIOMEDICAL, INC.
- Coronary Artery Probe 2.25mm — GENESEE BIOMEDICAL, INC.
- Coronary Artery Probe 2.25mm Long — GENESEE BIOMEDICAL, INC.
- Coronary Artery Probe 2.50mm — GENESEE BIOMEDICAL, INC.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Genesee Biomedical, Inc.
Sources (1)
- FDA UDI 86b8516d-26d2-4dd1-becb-058e602eb373 34 fields · synced May 31, 2026