Premier
- Primary DI
- D6911006063
- Brand
- Premier
- Company
- PREMIER DENTAL PRODUCTS COMPANY
- Model
- 1006063
- Device description
- NITROSPRAY PLUS LITE (10oz) DEMO
- 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 |
|---|---|---|---|---|
| D6911006063 | 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 |
|---|
| Liquid Chemical |
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
- false
- Serial number
- true
- 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
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|---|---|---|---|---|
| 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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