FDA UDI
In Commercial Distribution
🇺🇸 United States
Ascent OL5 Barrier Sleeve
DI: 00872320003401
·
Model: 02443
·
CAO GROUP, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- Ascent OL5 Barrier Sleeve
- Primary DI
- 00872320003401
- Version / Model
- 02443
- Company Name
- CAO GROUP, INC.
- Labeler DUNS
- 102422578
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-11-10
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- eaddc074-fbf0-4cd6-8cf7-4d7cdd64dec9
Device Description
Single-use barrier sleeve for use with the Ascent OL5 dental curing light.
Device Characteristics
- Single Use
- Yes
- 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 |
|---|---|---|---|---|
| EBZ | Activator, Ultraviolet, For Polymerization | Dental | 872.6070 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35775 | Dental/surgical polymerization lamp | A mains electricity (AC-powered), hand-held, device intended to be used to activate the polymerization of: 1) a dental resin-based material in the oral cavity; and/or 2) a surgical adhesive/sealant during an open-surgery procedure. It typically includes a light source [e.g., halogen, fluorescent, light-emitting diode (LED)] that emits light in the visible, or less frequently, ultraviolet spectrum, mounted in a handpiece that is typically attached to or used with a portable control unit or charging station. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00872320003401 | GS1 | ||||
| Package | 00872320003050 | GS1 | Pack | 250 | In Commercial Distribution | |
| Package | 00872320003074 | GS1 | Pack | 50 | In Commercial Distribution |
Customer Contacts
- Phone
- 877-236-4408
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K020057 | 000 |