FDA UDI
In Commercial Distribution
🇺🇸 United States
VELscope
DI: 07540201000025
·
Model: VELcap Vx
·
LED Dental Inc
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
1
Basic Information
- Brand Name
- VELscope
- Primary DI
- 07540201000025
- Version / Model
- VELcap Vx
- Catalog Number
- 5710
- Company Name
- LED Dental Inc
- Labeler DUNS
- 243167546
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 5
- Public Version Date
- 2021-11-10
- Public Version Status
- Update
- Public Device Record Key
- 18139c60-66ae-4fc8-a03d-c4f5365ac249
Device Characteristics
- Single Use
- Yes
- 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
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| NXV | Diagnostic Light, Soft Tissue Detector | Dental | 872.6350 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44711 | Optical medical device procedural cover | A device designed to fit over the distal end of a non-surgically-invasive device with optical functionality (e.g., laser beam-guide, optical scanning handpiece, endoscope) during use, to act as a cover/shield to avoid direct contact to the eye and/or cross-contamination between patients; it is not intended to act as a spacer. It is typically a small rigid partially- or fully- transparent plastic device. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07540201000025 | GS1 | ||||
| Package | 17540201000022 | GS1 | Dispenser Box-16 | 16 | In Commercial Distribution | |
| Package | 27540201000029 | GS1 | Corrugate Box-128 | 8 | In Commercial Distribution | |
| Package | 37540201000026 | GS1 | Master Carton-2048 | 16 | In Commercial Distribution |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K102083 | 000 |