J-PLASMA® PRECISE™ BVX-044-BPS
GUDID 10607151011861
J-PLASMA® PRECISE™ Open, 44mm
BOVIE MEDICAL CORPORATION
Endoscopic electrosurgical handpiece/electrode, monopolar, single-use| Primary Device ID | 10607151011861 |
| NIH Device Record Key | 7b1fcc7d-f5c5-4c85-b743-13a2277facb6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | J-PLASMA® PRECISE™ |
| Version Model Number | BVX-044-BPS |
| Catalog Number | BVX-044-BPS |
| Company DUNS | 079940465 |
| Company Name | BOVIE MEDICAL CORPORATION |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Operating and Storage Conditions
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00607151011864 [Primary] |
| GS1 | 10607151011861 [Package] Contains: 00607151011864 Package: BOX [1 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K170188
FDA Product Code
| GEI | Electrosurgical, Cutting & Coagulation & Accessories |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-02-21 |
| Device Publish Date | 2017-06-13 |
On-Brand Devices [J-PLASMA® PRECISE™]
| 00607151011987 | J-PLASMA® PRECISE™ FLEX, 500mm |
| 10607151011922 | J-PLASMA® PRECISE™ Open, 150mm |
| 10607151011915 | J-PLASMA® PRECISE™ Open, 44mm |
| 10607151011878 | J-PLASMA® PRECISE™ Open, 150mm |
| 10607151011861 | J-PLASMA® PRECISE™ Open, 44mm |
| 10607151010758 | J-PLASMA® PRECISE™ 360 LAPAROSCOPIC HAND DEVICE WITH NEEDLE TIP, 45cm |
| 10607151010741 | J-PLASMA® PRECISE™ 360 LAPAROSCOPIC HAND DEVICE WITH BLADE, 45cm |
| 10607151010734 | J-PLASMA® PRECISE™ 360 LAPAROSCOPIC HAND DEVICE WITH NEEDLE TIP, 33cm |
| 10607151010727 | J-PLASMA® PRECISE™ 360 LAPAROSCOPIC HAND DEVICE WITH BLADE, 33cm |
| 10607151010192 | J-PLASMA® PRECISE™ HANDPIECE NEEDLE TIP, 5MM-Ø 45CM-LENGTH, PISTOL GRIP |
| 10607151010185 | J-PLASMA® PRECISE™ HANDPIECE NEEDLE TIP, 5MM-Ø 33CM-LENGTH, PISTOL GRIP |
| 10607151010178 | J-PLASMA® PRECISE™ HANDPIECE NEEDLE TIP, 5MM-Ø 150CM-LENGTH, PISTOL GRIP |
| 10607151010161 | J-PLASMA® PRECISE™ HANDPIECE BLADE TIP, 5MM-Ø 45CM-LENGTH, PISTOL GRIP |
| 10607151010154 | J-PLASMA® PRECISE™ HANDPIECE BLADE TIP, 5MM-Ø 33CM-LENGTH, PISTOL GRIP |
| 10607151010147 | J-PLASMA® PRECISE™ HANDPIECE BLADE TIP, 5MM-Ø 150CM-LENGTH, PISTOL GRIP |
Trademark Results [J-PLASMA]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 J-PLASMA 85607645 4333822 Live/Registered |
Bovie Medical Corporation 2012-04-25 |
 J-PLASMA 79358942 not registered Live/Pending |
Weinert Industries AG 2022-08-23 |
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