FDA UDI
In Commercial Distribution
🇺🇸 United States
Fog-Free Photo Mirror Kit
DI: 00723896023747
·
Model: 7160914
·
PRACTICON, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Fog-Free Photo Mirror Kit
- Primary DI
- 00723896023747
- Version / Model
- 7160914
- Catalog Number
- 7160914
- Company Name
- PRACTICON, INC.
- Labeler DUNS
- 119193803
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-08-24
- Public Version
- 1
- Public Version Date
- 2023-09-01
- Public Version Status
- New
- Public Device Record Key
- 523e485e-46a0-4665-8bbb-fd66a1cb1f3f
Device Description
The Practicon® Fog-Free Photo Mirror features interchangeable polished stainless mirrors that slide securely into a lightweight plastic handle. Inside the handle, a battery-powered fan directs a gentle stream of air across the mirror surface to eliminate fogging. Five built-in LEDs help illuminate mouth for brighter photos and better focusing. Rechargeable, cordless operation with low battery indicator. Auto shut-off. Handle may be surface disinfected. Mirrors are fully autoclavable. One year warranty. Kit includes handle, USB charging cable, and one each L occlusal, M occlusal, buccal, and lingual mirrors.
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
- 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 |
|---|---|---|---|---|
| EAX | Mirror, Mouth | Dental | 872.4565 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 31776 | Dental mirror, reusable | A hand-held, dental instrument intended to be used by a dentist for intraoral inspection or inspection and retraction. It typically consists of a stainless steel shaft terminating at the distal end in a small round mirror that is angled to the shaft. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00723896023754 | GS1 | case | 60 | In Commercial Distribution | |
| Primary | 00723896023747 | GS1 |