FDA UDI
In Commercial Distribution
🇺🇸 United States
Endo CSV
DI: 00766054002857
·
Model: 5100-LED
·
ESSENTIAL DENTAL SYSTEMS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Endo CSV
- Primary DI
- 00766054002857
- Version / Model
- 5100-LED
- Catalog Number
- 5100-LED
- Company Name
- ESSENTIAL DENTAL SYSTEMS, INC.
- Labeler DUNS
- 101147171
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-07-17
- Public Version
- 1
- Public Version Date
- 2020-07-27
- Public Version Status
- New
- Public Device Record Key
- aed41cb7-d542-4955-8384-26ab8f3bc1fc
Device Description
Endo CSV LED Light
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
- Yes
- PM Exempt
- Yes
- 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
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EBA | LIGHT, SURGICAL HEADLIGHT | Dental | 872.4630 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 56318 | LED dental light, battery-powered | A battery-powered device designed for use in dentistry to project an intense and focused beam of light directly into or around the oral cavity of a patient via a light-emitting diode (LED), situated as the light head at the distal end of the device's light wand, to illuminate the site of a dental examination or procedure. The light head is connected to a light-intensity control unit, containing rechargeable batteries, via a flexible cable; for oral cavity illumination, the light wand may be attached to a suction cannula, a dental chair headrest, or to a retractor hooked on the patient's lower jaw. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00766054002857 | GS1 |
Customer Contacts
- Phone
- +1(201)487-9090
- [email protected]