Pomee
- Primary DI
- G1577117120
- Brand
- Pomee
- Company
- POMEE CORPORATION
- Model
- 711-712
- Catalog number
- 711-712
- Device description
- UNIVERSAL SCALER #12
- Published
- 2023-10-02
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- false
- OTC
- false
- Sterile
- true
- Single use
- false
Related Records
Product Codes
| Code | Name |
|---|---|
| EMS | Curette, Periodontic |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|---|---|---|
| EMS | Curette, Periodontic | Dental | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| G1577117120 | Primary | HIBCC | 0 |
GMDN Terms
| Term | Definition |
|---|---|
| Manual dental scaler, reusable | A hand-held dental instrument designed for removing calculus and other accretions from the surface and between the teeth during dental cleaning and periodontal (gum) therapy. It is typically designed as a one-piece instrument with a pointed, distal end of various shapes and sizes. Also known as a periodontic scaler, it can be a single-ended or double-ended instrument with a handle at the proximal end or positioned centrally. It is usually made of high-grade stainless steel. This is a reusable device. |
Sterilization Methods
| Method |
|---|
| Moist Heat or Steam Sterilization;Dry Heat Sterilization |
Regulatory Flags
- DUNS number
- 645717646
- Device count
- 1
- 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
Other Devices From This Company
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| G1577078910 | Pomee | 707-891 | 707-891 | 2025-06-14 |
| G1577078920 | Pomee | 707-892 | 707-892 | 2025-06-14 |
| G157PCAH0 | Pomee | PCAH | PCAH | 2024-07-05 |
| G157PCAP0 | Pomee | PCAP | PCAP | 2024-07-05 |
| G157PCAT0 | Pomee | PCAT | PCAT | 2024-07-05 |
| G157PCAV0 | Pomee | PCAV | PCAV | 2024-07-05 |
| G1577025400 | Pomee | 702-540 | 702-540 | 2023-10-18 |
| G1577025450 | Pomee | 702-545 | 702-545 | 2023-10-18 |
| G1577025500 | Pomee | 702-550 | 702-550 | 2023-10-18 |
| G1577072950 | Pomee | 707-295 | 707-295 | 2023-10-18 |
| G1577073000 | Pomee | 707-300 | 707-300 | 2023-10-18 |
| G1577073050 | Pomee | 707-305 | 707-305 | 2023-10-18 |
| G1577073100 | Pomee | 707-310 | 707-310 | 2023-10-18 |
| G1577078100 | Pomee | 707-810 | 707-810 | 2023-10-18 |
| G1577078120 | Pomee | 707-812 | 707-812 | 2023-10-18 |
| G1577078150 | Pomee | 707-815 | 707-815 | 2023-10-18 |
| G1577078170 | Pomee | 707-817 | 707-817 | 2023-10-18 |
| G1577078200 | Pomee | 707-820 | 707-820 | 2023-10-18 |
| G1577078250 | Pomee | 707-825 | 707-825 | 2023-10-18 |
| G1577078300 | Pomee | 707-830 | 707-830 | 2023-10-18 |
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