Waterpik Original Tofflemire Matrix Bands
- Primary DI
- D6863457890
- Brand
- Waterpik Original Tofflemire Matrix Bands
- Company
- WATER PIK, INC.
- Model
- 34578-9
- Catalog number
- 34578-9
- Device description
- No. 1 Adult Universal
- Published
- 2020-08-31
- 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 Codes
| Code | Name |
|---|
| DZN | Instruments, Dental Hand |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| DZN | Instruments, Dental Hand | Dental | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| D6863457893 | Primary | HIBCC | 0 | |
| D6863457890 | Unit of Use | HIBCC | 0 | |
GMDN Terms
| Term | Definition |
|---|
| Dental matrix band, single-use | A band or strip of strong material (typically a transparent plastic) or a short tube that is used to form a mould around a tooth for the insertion of restorative materials. The device is typically held snugly around the tooth by a matrix retainer. This is a single-use device. |
Device Sizes
| Type | Value | Unit |
|---|
| Depth | 0.0015 | Inch |
Sterilization Methods
| Method |
|---|
| Moist Heat or Steam Sterilization |
Regulatory Flags
- DUNS number
- 001804074
- Device count
- 36
- 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
- true
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