FDA UDI
In Commercial Distribution
🇺🇸 United States
Bovie
DI: 00607151008932
·
Model: SEPAT
·
BOVIE MEDICAL CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Bovie
- Primary DI
- 00607151008932
- Version / Model
- SEPAT
- Catalog Number
- SEPAT
- Company Name
- BOVIE MEDICAL CORPORATION
- Labeler DUNS
- 079940465
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-16
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 7fd2e468-3e72-4d16-a8da-f06a4bcc2744
Device Description
ELECTROSURGERY PENCIL ADAPTER WITH 3/8” (.952cm) X 4” (121.92cm) CONNECTED TO 7/8” (2.22cm) X 6’ (1.8288m) HOSE
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
- Yes
- 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 |
|---|---|---|---|---|
| FYD | Apparatus, Exhaust, Surgical | General, Plastic Surgery | 878.5070 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46483 | Surgical plume evacuation system tube | A sterile, long, hollow cylinder which, as part of a surgical smoke evacuation system, is used to capture and conduct to exhaust the plume generated during open surgical procedures in which there is tissue ablation (e.g., laser surgery, electrocautery, electrosurgical diathermy device). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10607151008939 | GS1 | BOX | 10 | In Commercial Distribution | |
| Primary | 00607151008932 | GS1 |