FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Power Slot
DI: D798LED11MMP0
·
Model: LED11MMP
·
RELIANCE ORTHODONTIC PRODUCTS INC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Power Slot
- Primary DI
- D798LED11MMP0
- Version / Model
- LED11MMP
- Catalog Number
- LED11MMP
- Company Name
- RELIANCE ORTHODONTIC PRODUCTS INC
- Labeler DUNS
- 113170088
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-20
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 44c49ac4-1976-49a2-b4b4-377fa9c49b7b
- Distribution End Date
- 2017-12-21
Device Description
11 mm LED Power Slot
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
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- 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 |
|---|---|---|---|---|
| ECP | Instrument, Ligature Tucking, Orthodontic | Dental | 872.4565 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 48101 | Dental photo-activated disinfection system handpiece light guide | A detachable component of a dental photo-activated disinfection system that is attached to the distal end of the system's handpiece and designed to guide and transmit the photo-activating light from the handpiece into the hard and soft tissue within the oral cavity as part of the bacteria-eliminating process. The device is typically a rigid, curved tube containing a fibreoptic core and is sterilized between patients. It can be used without the attachment of a dedicated tip when larger tissue areas are to be treated. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | D798LED11MMP0 | HIBCC |
Customer Contacts
- Phone
- 6307734009
- [email protected]