Bovie · LS05
ASPEN SURGICAL PRODUCTS, INC. · Laparoscopic Spatula Electrode With 4mm (.157") Adapter (5/bx)
Open FDA's page for this record- Has donation ID number
- false
- Mri safety
- Labeling does not contain MRI Safety Information
- Record status
- Published
- Is labeled as nrl
- false
- Is rx
- true
- Commercial distribution status
- In Commercial Distribution
- Device description
- Laparoscopic Spatula Electrode With 4mm (.157") Adapter (5/bx)
- Public device record key
- 0d6e9442-3511-43c8-9aa9-5bd21b4fb401
- Has serial number
- false
- Public version date
- 2026-05-07
- Is direct marking exempt
- false
- Public version number
- 4
- Labeler duns number
- 027680821
- Is labeled as no nrl
- false
- Is single use
- true
- Is otc
- false
- Version or model number
- LS05
- Has manufacturing date
- true
- Brand name
- Bovie
- Is combination product
- false
- Is kit
- false
- Device count in base package
- 1
- Is pm exempt
- false
- Has lot or batch number
- true
- Company name
- ASPEN SURGICAL PRODUCTS, INC.
- Public version status
- Update
- Has expiration date
- true
- Is hct p
- false
- Publish date
- 2024-08-20
- Sterilization
- Is sterile
- true
- Is sterilization prior use
- false
- Identifiers
- ID
- 00887482179970
- Type
- Package
- Issuing agency
- GS1
- Unit of use ID
- 10887482179960
- Quantity per package
- 5
- Package status
- In Commercial Distribution
- ID
- 10887482179960
- Type
- Primary
- Issuing agency
- GS1
- Product codes
- Code
- GEI
- Name
- Electrosurgical, Cutting & Coagulation & Accessories
- Harmonized identifiers (openFDA)
- Device name
- Electrosurgical, Cutting & Coagulation & Accessories
- Medical specialty description
- General, Plastic Surgery
- Regulation number
- 878.4400
- Device class
- 2
- Customer contacts
- Phone
- 1 888-364-7004
- customerservice@aspensurgical.com
- Gmdn terms
- Code
- 61874
- Name
- Open-surgery electrosurgical electrode, monopolar, single-use
- Implantable
- false
- Code status
- Active
- Definition
An invasive, monopolar, electrical conductor intended to be attached to an appropriate handle/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 single-use device intended to be used in a sterile condition.
- Device sizes
- Type
- Width
- Value
- 4
- Unit
- Millimeter
