Pomee
- Primary DI
- G1577133040
- Brand
- Pomee
- Company
- POMEE CORPORATION
- Model
- 713-304
- Catalog number
- 713-304
- Device description
- PK THOMAS WAX #4
- Published
- 2023-10-11
- 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
Product Codes
| Code | Name |
|---|
| EIK | Carver, Wax, Dental |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| EIK | Carver, Wax, Dental | Dental | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| G1577133040 | Primary | HIBCC | 0 | |
GMDN Terms
| Term | Definition |
|---|
| Dental wax carver | A hand-held manual dental instrument used to carve wax patterns with a blunt blade of varying size and shape, which can be heated for softening the wax while fashioning the pattern. 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
Other Devices Sharing Product Codes
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|---|
| 08404535024906 | Brasseler USA | Peter Brasseler Holdings, LLC | EIK | 2026-03-23 |
| 08404535024937 | Brasseler USA | Peter Brasseler Holdings, LLC | EIK | 2026-03-23 |
| 08404535024968 | Brasseler USA | Peter Brasseler Holdings, LLC | EIK | 2026-03-23 |
| 00840018666016 | Nordent Manufacturing, Inc. | NORDENT MANUFACTURING INC | EIK | 2026-02-09 |
| 00840018663671 | Nordent Manufacturing, Inc. | NORDENT MANUFACTURING INC | EIK | 2026-02-04 |
| 00840018665293 | Nordent Manufacturing, Inc. | NORDENT MANUFACTURING INC | EIK | 2026-02-04 |
| 00840018665439 | Nordent Manufacturing, Inc. | NORDENT MANUFACTURING INC | EIK | 2026-02-04 |
| 00840018665446 | Nordent Manufacturing, Inc. | NORDENT MANUFACTURING INC | EIK | 2026-02-04 |
| 00840018663305 | Nordent Manufacturing, Inc. | NORDENT MANUFACTURING INC | EIK | 2026-01-29 |
| 00840018661172 | Nordent Manufacturing, Inc. | NORDENT MANUFACTURING INC | EIK | 2026-01-28 |
| 00840018661301 | Nordent Manufacturing, Inc. | NORDENT MANUFACTURING INC | EIK | 2026-01-28 |
| 00813677024145 | PDT, Inc. | PDT, INC. | EIK | 2024-06-27 |
| 00813677024152 | PDT, Inc. | PDT, INC. | EIK | 2024-06-27 |
| 00813677024169 | PDT, Inc. | PDT, INC. | EIK | 2024-06-27 |
| 00813677024176 | PDT, Inc. | PDT, INC. | EIK | 2024-06-27 |
| 00813677024183 | PDT, Inc. | PDT, INC. | EIK | 2024-06-27 |
| 00310866002644 | GET SCULPTED | PASCAL COMPANY, INC. | EIK | 2024-05-16 |
| 00842517119352 | Karl Schumacher | Karl Schumacher Dental, LLC | EIK | 2024-05-06 |
| 08800075626479 | OSUNG MND | OSUNG MND Co., Ltd. | EIK | 2024-03-06 |
| 08800075626516 | OSUNG MND | OSUNG MND Co., Ltd. | EIK | 2024-03-06 |
| 08800075626486 | OSUNG MND | OSUNG MND Co., Ltd. | EIK | 2024-02-23 |
| 08800075626493 | OSUNG MND | OSUNG MND Co., Ltd. | EIK | 2024-02-23 |
| 08800075626509 | OSUNG MND | OSUNG MND Co., Ltd. | EIK | 2024-02-23 |
| 08800075626523 | OSUNG MND | OSUNG MND Co., Ltd. | EIK | 2024-02-23 |
| G1577046890 | Pomee | POMEE CORPORATION | EIK | 2023-10-16 |
| G1577132500 | Pomee | POMEE CORPORATION | EIK | 2023-10-11 |
| G1577132700 | Pomee | POMEE CORPORATION | EIK | 2023-10-11 |
| G1577132750 | Pomee | POMEE CORPORATION | EIK | 2023-10-11 |
| G1577132770 | Pomee | POMEE CORPORATION | EIK | 2023-10-11 |
| G1577133030 | Pomee | POMEE CORPORATION | EIK | 2023-10-11 |