FDA UDI
In Commercial Distribution
🇺🇸 United States
Visix
DI: 00851800007092
·
Model: for Intraoral Camera 2.3.10
·
TELEVERE SYSTEMS, LLC
Product Codes
1
GMDN Terms
2
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Visix
- Primary DI
- 00851800007092
- Version / Model
- for Intraoral Camera 2.3.10
- Catalog Number
- Visix for Intraoral Camera 2.3.10
- Company Name
- TELEVERE SYSTEMS, LLC
- Labeler DUNS
- 127132269
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-10-10
- Public Version
- 7
- Public Version Date
- 2023-10-18
- Public Version Status
- Update
- Public Device Record Key
- 69d42719-b1f0-4d37-898d-4ce2f01d2a15
Device Description
Visix software for use with just an intraoral camera version 2.3.10
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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 |
|---|---|---|---|---|
| LLZ | System, Image Processing, Radiological | Radiology | 892.2050 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38683 | Camera application software | A data program designed for use in, or together with, a camera (e.g., a digital camera or video recorder) so that it may function according to its intended purpose. This software program can be permanently installed, or exchanged as an upgrade. It may also be produced for installation in an off-the-shelf desktop or laptop computer. | No | Active |
| 41670 | Radiological PACS software | An individual software application intended to be installed on a central server as part of a picture archiving and communication system (PACS) to allow storage, retrieval, analysis, and management of radiological images. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00851800007092 | GS1 |
Customer Contacts
- Phone
- 518-243-9705
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K082623 | 000 |