Vis-Rx Prime
- Primary DI
- 00859910007148
- Brand
- Vis-Rx Prime
- Company
- GENTUITY LLC
- Model
- G31
- Catalog number
- G31-01
- Device description
- 1.8F Rapid exchange micro-imaging high-frequency OCT catheter kit - US
- Published
- 2025-04-09
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- Sterile
- true
- Single use
- true
Product Codes#
| Code | Name |
|---|---|
| DQO | Catheter, Intravascular, Diagnostic |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| DQO | Catheter, Intravascular, Diagnostic | Cardiovascular | 2 |
Premarket Submissions#
| Submission | Supplement |
|---|---|
| K242966 | 000 |
Premarket Details#
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 00859910007148 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 00859910007148 | 00859910007148 | 859910007148 | 0859910007148 |
GMDN Terms#
| Term | Definition |
|---|---|
| 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. |
Device Sizes#
| Type | Value | Unit |
|---|---|---|
| Catheter Gauge | 1.8 | French |
Sterilization Methods#
| Method |
|---|
Regulatory Flags#
- DUNS number
- 077509759
- Device count
- 1
- Kit
- true
- Lot or batch
- true
- Manufacturing date on label
- true
- Expiration date on label
- true
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 00859910007032 | Gentuity HF-OCT Imaging System | SW 23.3.13 | G10-01 | 2021-06-22 |
| 00859910007018 | Vis-Rx | US Catheter Kit G30-01 | 2021-02-11 | |
| 00859910007049 | Gentuity | Gentuity Review Station | G80-01 | 2022-08-17 |
Other Devices Sharing Product Codes#
| Primary DI | Brand | Company | Product code | Published |
|---|---|---|---|---|
| 00885403522270 | Swan-Ganz | Becton, Dickinson And Company | DQO | 2026-05-30 |
| 00885403522386 | Swan-Ganz | Becton, Dickinson And Company | DQO | 2026-05-30 |
| 00884450766958 | Performa® | Merit Medical Systems, Inc. | DQO | 2026-05-28 |
| 07613327313956 | Trevo Trak 21 | Stryker Corporation | DQO | 2020-04-17 |
| 08714729152989 | Impulse™ | BOSTON SCIENTIFIC CORPORATION | DQO | 2016-09-24 |
| 08714729188865 | Impulse™ | BOSTON SCIENTIFIC CORPORATION | DQO | 2016-09-24 |
| 08714729200291 | Impulse™ | BOSTON SCIENTIFIC CORPORATION | DQO | 2016-09-24 |
| 08714729213161 | Impulse™ | BOSTON SCIENTIFIC CORPORATION | DQO | 2016-09-24 |
| 08714729213178 | Impulse™ | BOSTON SCIENTIFIC CORPORATION | DQO | 2016-09-24 |
| 08714729213185 | Impulse™ | BOSTON SCIENTIFIC CORPORATION | DQO | 2016-09-24 |
| 08714729213192 | Impulse™ | BOSTON SCIENTIFIC CORPORATION | DQO | 2016-09-24 |
| 08714729213208 | Impulse™ | BOSTON SCIENTIFIC CORPORATION | DQO | 2016-09-24 |
| 08714729213369 | Impulse™ | BOSTON SCIENTIFIC CORPORATION | DQO | 2016-09-24 |
| 08714729213666 | Impulse™ | BOSTON SCIENTIFIC CORPORATION | DQO | 2016-09-24 |
| 08714729213741 | Impulse™ | BOSTON SCIENTIFIC CORPORATION | DQO | 2016-09-24 |
| 08714729213888 | Impulse™ | BOSTON SCIENTIFIC CORPORATION | DQO | 2016-09-24 |
| 08714729213918 | Impulse™ | BOSTON SCIENTIFIC CORPORATION | DQO | 2016-09-24 |
| 08714729214007 | Impulse™ | BOSTON SCIENTIFIC CORPORATION | DQO | 2016-09-24 |
| 08714729214083 | Impulse™ | BOSTON SCIENTIFIC CORPORATION | DQO | 2016-09-24 |
| 08714729214120 | Impulse™ | BOSTON SCIENTIFIC CORPORATION | DQO | 2016-09-24 |
| 08714729214168 | Impulse™ | BOSTON SCIENTIFIC CORPORATION | DQO | 2016-09-24 |
| 08714729214243 | Impulse™ | BOSTON SCIENTIFIC CORPORATION | DQO | 2016-09-24 |
| 08714729214342 | Impulse™ | BOSTON SCIENTIFIC CORPORATION | DQO | 2016-09-24 |
| 08714729214380 | Impulse™ | BOSTON SCIENTIFIC CORPORATION | DQO | 2016-09-24 |
| 08714729214441 | Impulse™ | BOSTON SCIENTIFIC CORPORATION | DQO | 2016-09-24 |
| 08714729214472 | Impulse™ | BOSTON SCIENTIFIC CORPORATION | DQO | 2016-09-24 |
| 08714729214502 | Impulse™ | BOSTON SCIENTIFIC CORPORATION | DQO | 2016-09-24 |
| 08714729214632 | Impulse™ | BOSTON SCIENTIFIC CORPORATION | DQO | 2016-09-24 |
| 08714729214656 | Impulse™ | BOSTON SCIENTIFIC CORPORATION | DQO | 2016-09-24 |
| 08714729214663 | Impulse™ | BOSTON SCIENTIFIC CORPORATION | DQO | 2016-09-24 |