FDA UDI
In Commercial Distribution
🇺🇸 United States
Vis-Rx Prime
DI: 00859910007148
·
Model: G31
·
GENTUITY LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Vis-Rx Prime
- Primary DI
- 00859910007148
- Version / Model
- G31
- Catalog Number
- G31-01
- Company Name
- GENTUITY LLC
- Labeler DUNS
- 077509759
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-04-09
- Public Version
- 1
- Public Version Date
- 2025-04-17
- Public Version Status
- New
- Public Device Record Key
- 81bd4b2c-fa27-4840-9129-5b244040826c
Device Description
1.8F Rapid exchange micro-imaging high-frequency OCT catheter kit - US
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- 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
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| DQO | Catheter, Intravascular, Diagnostic | Cardiovascular | 870.1200 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47491 | Coronary optical coherence tomography system catheter | A sterile flexible tube with an extremely fine working end that houses an optical fibre and imaging lens intended to be transcutaneously introduced into the coronary vasculature to perform coronary optical coherence tomography (OCT). The proximal end of the device connects to a coronary OCT console for the transmission of high-resolution images (e.g., 5 to 40 micron) of the coronary intravasculature. It is typically made of stainless steel, plastic, and optical materials. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00859910007148 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K242966 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Catheter Gauge | 1.8 | French |