FDA UDI
In Commercial Distribution
🇺🇸 United States
NvisionVLE Imaging System with Targeted Biopsy - Upgrade
DI: 00859591006218
·
Model: 94301-M-UPG
·
NINEPOINT MEDICAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- NvisionVLE Imaging System with Targeted Biopsy - Upgrade
- Primary DI
- 00859591006218
- Version / Model
- 94301-M-UPG
- Catalog Number
- 94301-M-UPG
- Company Name
- NINEPOINT MEDICAL, INC.
- Labeler DUNS
- 961880999
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-22
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 684e3d40-2c16-4b25-8d04-2d2f1d4105fa
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
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NQQ | System, Imaging, Optical Coherence Tomography (Oct) | Radiology | 892.1560 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62326 | Endoscopic optical coherence tomography system | An assembly of mains electricity-powered (AC-powered) devices designed to produce microscopic cross-sectional images of tissues within non-vascular luminal structures [e.g., gastrointestinal tract (GI), urinary tract, respiratory tract] during an endoscopic procedure or ex-vivo. It uses optical coherence tomography (OCT) whereby a light beam provides real-time, in-depth, high-resolution imagery by means of volumetric laser endomicroscopy (VLE) technology; it may also provide tissue laser marking for visual referencing. It consists of a mobile console with display/controls, an endoscopic fibreoptic probe, and a probe inflation device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00859591006218 | GS1 |
Customer Contacts
- Phone
- 855-900-7205
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K153479 | 000 |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- -20 – 60 Degrees Celsius
- Type
- Handling Environment Humidity
- Temperature Range
- 15 – 95 Percent (%) Relative Humidity