Unique device identifiers (GUDID)

Bovie · LS05

ASPEN SURGICAL PRODUCTS, INC. · Laparoscopic Spatula Electrode With 4mm (.157") Adapter (5/bx)

DI 00887482179970RxIn Commercial DistributionGEI
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
  1. ID
    00887482179970
    Type
    Package
    Issuing agency
    GS1
    Unit of use ID
    10887482179960
    Quantity per package
    5
    Package status
    In Commercial Distribution
  2. ID
    10887482179960
    Type
    Primary
    Issuing agency
    GS1
Product codes
  1. 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
  1. Phone
    1 888-364-7004
    Email
    customerservice@aspensurgical.com
Gmdn terms
  1. 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
  1. Type
    Width
    Value
    4
    Unit
    Millimeter
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.