FDA UDI
In Commercial Distribution
🇺🇸 United States
J-PLASMA® PRECISE™
DI: 00607151011925
·
Model: BVX -150-BPP
·
ASPEN SURGICAL PRODUCTS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- J-PLASMA® PRECISE™
- Primary DI
- 00607151011925
- Version / Model
- BVX -150-BPP
- Catalog Number
- BVX -150-BPP
- Company Name
- ASPEN SURGICAL PRODUCTS, INC.
- Labeler DUNS
- 027680821
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-06-13
- Public Version
- 7
- Public Version Date
- 2025-12-30
- Public Version Status
- Update
- Public Device Record Key
- 060a83e7-f3ea-4a3c-a45b-739c7044afb1
Device Description
J-PLASMA® PRECISE™ Open, 150mm
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | General, Plastic Surgery | 878.4400 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44681 | Electrosurgical handpiece, single-use | A hand-held component of an electrosurgical system intended to provide an electrical connection between the system generator and a detachable electrode at its distal end, enabling the surgeon controlled manipulation of the electrode during surgery; the electrode is not included. The device is typically in the form of a pen with permanently attached cables for connection to a generator; it is not intended for use during inert gas-enhanced electrosurgery. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10607151011922 | GS1 | BOX | 1 | In Commercial Distribution | |
| Primary | 00607151011925 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K170188 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 10 – 30 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 10 – 75 Percent (%) Relative Humidity