FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Bovie
DI: 10887482177645
·
Model: AR03
·
ASPEN SURGICAL PRODUCTS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Bovie
- Primary DI
- 10887482177645
- Version / Model
- AR03
- Company Name
- ASPEN SURGICAL PRODUCTS, INC.
- Labeler DUNS
- 027680821
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-08-26
- Public Version
- 3
- Public Version Date
- 2025-10-29
- Public Version Status
- Update
- Public Device Record Key
- 2b95f204-a4f5-435d-b1cc-eb0ca411624a
- Distribution End Date
- 2025-01-06
Device Description
Bovie® Arthroscopy Electrode Meniscectomy (5/bx)
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
- Yes
- 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 |
|---|---|---|---|---|
| 61876 | Open-surgery electrosurgical electrode, monopolar, reusable | An invasive, monopolar, electrical conductor intended to be attached to an electrosurgical handpiece (not included) to deliver electrosurgical current directly to tissues for cutting/coagulation during an open surgical procedure. It may be available in a variety of forms (e.g., blade, ball, loop, needle, spatula) and requires a patient contact return electrode to complete the circuit. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00887482177655 | GS1 | 5 | Not in Commercial Distribution | 2025-01-06 | |
| Primary | 10887482177645 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K020579 | 000 |