FDA UDI
In Commercial Distribution
🇺🇸 United States
Coronary Artery Probe 2.00mm Long
DI: B040CPH200L0
·
Model: CPH-2.00L
·
GENESEE BIOMEDICAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Coronary Artery Probe 2.00mm Long
- Primary DI
- B040CPH200L0
- Version / Model
- CPH-2.00L
- Company Name
- GENESEE BIOMEDICAL, INC.
- Labeler DUNS
- 939872651
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-12-05
- Public Version
- 1
- Public Version Date
- 2024-12-13
- Public Version Status
- New
- Public Device Record Key
- c47f1c50-ffac-4d32-ad27-df9ab1ac4aa0
Device Description
Reusable Probe for Coronary Arteries Assorted sizes 1mm to 3mm as indicated by its part number 191mm Length
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| DWS | Instruments, Surgical, Cardiovascular | Cardiovascular | 870.4500 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 11268 | Vascular dilator, reusable | A hand-held surgical instrument designed for insertion into a blood vessel (the vasculature) to unblock, enlarge or measure the internal diameter of the vessel during a surgical intervention. It is a rod-like device with a long, slender, body that terminates with a bulbous, cylindrical distal tip of various shapes and sizes. Commonly known as a vessel dilator or vascular probe, it is available in a variety of sizes (diameters and lengths) and flexibilities. It is typically made of metal or plastic materials. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | B040CPH200L1 | HIBCC | 1 | In Commercial Distribution | ||
| Primary | B040CPH200L0 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K901531 | 000 |