Premier
NITROSPRAY PLUS LITE (10oz) LOANER
3manufacturers in China registered for this device type
30catalogue numbers in this listing
1510(k) clearance
2recalls on this code
Who Else Makes It
Concentrated in Guangdong (1), Beijing (1), Tianjin (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shenzhen Kesite Digital Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 4 |
| Hygea Medical Technology Co., Ltd. | Beijing | Beijing | Manufacturer | 2 |
| Medinux (Tianjin) Technologies Co., Ltd. | Tianjin | Tianjin | Manufacturer | 1 |
Record
| Listed by | Premier Dental Products Co., United States |
|---|---|
| FDA product code | GEH |
| Device type | Unit, Cryosurgical, Accessories |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4350 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Record published | 2016-09-23 |
| Record revised | 2021-04-07 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1006606 | In distribution | |
| 1006635 | In distribution | |
| 1006060 | In distribution | |
| 1006521 | In distribution | |
| 1006735 | In distribution | |
| 1006650 | In distribution | |
| 1006518 | In distribution | |
| 1006520 | In distribution | |
| 1006516 | In distribution | |
| 1006065 | In distribution | |
| 1006700 | In distribution | |
| 1006519 | In distribution | |
| 1006073 | In distribution | |
| 1006517 | In distribution | |
| 1006062 | In distribution | |
| 1006625 | In distribution | |
| 1006063 | In distribution | |
| 1006610 | In distribution | |
| 1006525 | In distribution | |
| 1006530 | In distribution | |
| 1006665 | In distribution | |
| 1006602 | In distribution | |
| 1006527 | In distribution | |
| 1006608 | In distribution | |
| 1006615 | In distribution | |
| 1006604 | In distribution | |
| 1006670 | In distribution | |
| 1006640 | In distribution | |
| 1006072 | In distribution | |
| 1006066 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Frigitronics | Coopersurgical, Inc. | 42 |
| CryoProbe™ | H&O Equipments, Nv/Sa | 35 |
| Wallach | Coopersurgical, Inc. | 32 |
| Hygea | Hygea Medical Technology Co., Ltd. | 26 |
| truFreeze | CSA Medical | 20 |
| Freezpen® | H&O Equipments, Nv/Sa | 19 |
| Leisegang Cryotip for LM-900 | Coopersurgical, Inc. | 15 |
| Integra® Miltex® | Integra LifeSciences Production Corporation | 13 |
| cryoICE Cryoablation System | Atricure, Inc. | 13 |
| CryoThin | Medinux (Tianjin) Technologies Co., Ltd. | 12 |
| Erbe | Erbe Elektromedizin GmbH | 12 |
| CVS Health | Woonsocket Prescription Center, Incorporated | 10 |
Showing 12 of 334. All products under Unit, Cryosurgical, Accessories
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K970992 | 1997-06-17 |
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2004-04-29 | Not classified | Other | Cryogen can escape from canister through the seal ring | 952 units | 2006-06-07 |
| 2004-04-29 | Not classified | Other | Cryogen can escape from canister through the seal ring | 1060 units | 2006-06-07 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.