Flecta Disposable Mirrors
- Primary DI
- D701FLEC2
- Brand
- Flecta Disposable Mirrors
- Company
- PULPDENT CORPORATION
- Model
- FLEC
- Device description
- Box of 200
- Published
- 2021-09-21
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- false
- OTC
- false
- Sterile
- false
- Single use
- true
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| EAX | Mirror, Mouth | Dental | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| D701FLEC2 | Primary | HIBCC | 0 | |
| D701FLEC1 | Unit of Use | HIBCC | 0 | |
GMDN Terms
| Term | Definition |
|---|
| 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. |
Regulatory Flags
- DUNS number
- 001006089
- Device count
- 200
- DM exempt
- false
- Premarket exempt
- true
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- false
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
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