Premier
- Primary DI
- D6911006615
- Brand
- Premier
- Company
- PREMIER DENTAL PRODUCTS COMPANY
- Model
- 1006615
- Device description
- CUTANEOUS PROBE SET OF 5
- Published
- 2016-09-23
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- false
- Single use
- false
Related Records
Product Codes
| Code | Name |
|---|---|
| GEH | Unit, Cryosurgical, Accessories |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|---|---|---|
| GEH | Unit, Cryosurgical, Accessories | General, Plastic Surgery | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| D6911006615 | Primary | HIBCC | 0 |
GMDN Terms
| Term | Definition |
|---|---|
| General cryosurgical system, cryogen gas, mechanical | An assembly of devices designed to apply cold from a gaseous or liquid refrigerant (cryogen) [e.g., liquid nitrogen (LN2), nitrous oxide (N2O), carbon dioxide (CO2)] to a target tissue for its destruction and removal. The system typically includes a mechanical regulator to control the flow of cryogen, contained in an attached cylinder, and the probe(s) to apply the cold. The system is used across clinical specialties (e.g., general surgery, dermatology, oral surgery, gynaecology, urology, ENT, proctology, oncology) to remove malignant or abnormal benign tissues. |
Sterilization Methods
| Method |
|---|
| Moist Heat or Steam Sterilization |
Regulatory Flags
- DUNS number
- 014789663
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- true
- 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 |
|---|---|---|---|---|
| 00348783004069 | Premier Elevator | 1003360 | 1003362 | 2026-03-17 |
| 00348783004076 | Premier Elevator | 1003361 | 1003363 | 2026-03-17 |
| 00348783004182 | Premier Elevator | 1003384 | 1003386 | 2026-03-17 |
| 00348783004229 | Premier Elevator | 1003394 | 1003396 | 2026-03-17 |
| 00348783005929 | Premier Explorers | 1003509 | 2026-03-17 | |
| 00348783005974 | Premier Explorers | 1003515 | 2026-03-17 | |
| 00348783005998 | Premier Explorers | 1003523 | 2026-03-17 | |
| 00348783006018 | Premier Explorers | 1003526 | 2026-03-17 | |
| 00348783006056 | Premier Explorers | 1003539 | 2026-03-17 | |
| 00348783006063 | Premier Explorers | 1003549 | 2026-03-17 | |
| 00348783006186 | Premier Explorers | 1003560 | 2026-03-17 | |
| 00348783006223 | Premier Explorers | 1003565 | 2026-03-17 | |
| 00348783006438 | Premier Probes | 1003670 | 2026-03-17 | |
| 00348783006629 | Premier Probes | 1003690 | 2026-03-17 | |
| 00348783006766 | Premier Probes | 9006102 | 2026-03-17 | |
| 00348783006780 | Premier Probes | 9006105 | 2026-03-17 | |
| 00348783006803 | Premier Probes | 9006107 | 2026-03-17 | |
| 00348783006810 | Premier Probes | 9006108 | 2026-03-17 | |
| 00348783006827 | Premier Probes | 9006120 | 2026-03-17 | |
| 00348783006841 | Premier Probes | 9006122 | 2026-03-17 |
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| 06935650603216 | HYGEA | Hygea Medical Technology Co., Ltd. | GEH | 2025-09-08 |
| 06935650603223 | HYGEA | Hygea Medical Technology Co., Ltd. | GEH | 2025-09-08 |
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| 07350006441011 | CryoIQ 25g N2O cartridge | CryoIQ global AB | GEH | 2025-07-16 |
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