FDA UDI
In Commercial Distribution
🇺🇸 United States
Coltolux Comfort
DI: 07630392901437
·
Model: 60034393
·
Dent4You AG
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1000
Basic Information
- Brand Name
- Coltolux Comfort
- Primary DI
- 07630392901437
- Version / Model
- 60034393
- Company Name
- Dent4You AG
- Labeler DUNS
- 480152811
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1000
- Record Status
- Published
- Publish Date
- 2023-02-01
- Public Version
- 1
- Public Version Date
- 2023-02-09
- Public Version Status
- New
- Public Device Record Key
- 174dfe45-51f0-4bf5-a4d1-440f66438369
Device Description
BARRIER SLEEVES, 1000PK
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
- 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 |
|---|---|---|---|---|
| EBZ | Activator, Ultraviolet, For Polymerization | Dental | 872.6070 | 2 |
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 |
|---|---|---|---|---|---|---|
| Unit of Use | 17630392901434 | GS1 | ||||
| Primary | 07630392901437 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K223142 | 000 |