FDA.reportPublic FDA data

ASSI

Primary DI
00841645103769
Brand
ASSI
Company
ACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORPORATION
Model
AC2505
Device description
Lletz Leep Loop Electrodes,15mm X 15mm, 10cm Lg.
Published
2016-09-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
JOSElectrode, Electrosurgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JOSElectrode, ElectrosurgicalGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841645103769PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841645103769008416451037698416451037690841645103769

GMDN Terms#

Term, Definition table
TermDefinition
Open-surgery electrosurgical electrode, monopolar, reusableAn 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.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
055870299
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841645131991ASSIASSI.FOC178/752020-06-30
00841645119371ASSIASSI.125262020-06-25
00841645119425ASSIASSI.129262020-06-25
00841645103325ASSIASSI.FOAL2682016-09-26
00841645131830ASSIASSI.FOAE1632016-09-26
00841645131847ASSIASSI.FOAE1642016-09-26
00841645131854ASSIASSI.FOAE1652016-09-26
00841645131861ASSIASSI.FOAHL2802016-09-26
00841645131878ASSIASSI.FOAL2602016-09-26
00841645131885ASSIASSI.FOAL2612016-09-26
00841645131892ASSIASSI.FOAL2622016-09-26
00841645131908ASSIASSI.FOAL2662016-09-26
00841645131915ASSIASSI.FOAL2672016-09-26
00841645131922ASSIASSI.FOAL2712016-09-26
00841645131939ASSIASSI.FOC158/62016-09-26
00841645131946ASSIASSI.FOC158/752016-09-26
00841645131953ASSIASSI.FOC158/982016-09-26
00841645131960ASSIASSI.FOC171/62016-09-26
00841645131977ASSIASSI.FOC171/752016-09-26
00841645131984ASSIASSI.FOC171/982016-09-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809295141007BIG-TIP™ RF Medical Co.,Ltd.JOS2025-09-05
08800142925092THYBLATE-V2™RF Medical Co.,Ltd.JOS2025-02-05
08800142925108THYBLATE-V2™RF Medical Co.,Ltd.JOS2025-02-05
08800142925115THYBLATE-V2™RF Medical Co.,Ltd.JOS2025-02-05
08800142925122THYBLATE-V2™RF Medical Co.,Ltd.JOS2025-02-05
04050147022751ErbeErbe Elektromedizin GmbHJOS2025-01-21
04050147022768ErbeErbe Elektromedizin GmbHJOS2025-01-21
04050147022775ErbeErbe Elektromedizin GmbHJOS2025-01-21
04050147022782ErbeErbe Elektromedizin GmbHJOS2025-01-21
04050147023543ErbeErbe Elektromedizin GmbHJOS2025-01-21
04050147023550ErbeErbe Elektromedizin GmbHJOS2025-01-21
04050147023567ErbeErbe Elektromedizin GmbHJOS2025-01-21
04050147023574ErbeErbe Elektromedizin GmbHJOS2025-01-21
00821925008083BovieGyrus ACMI, LLCJOS2024-07-25
00821925008458BovieGyrus ACMI, LLCJOS2024-07-25
00845854030632CONMEDConmed CorporationJOS2023-12-05
08800142919206THYBLATE-V™RF Medical Co.,Ltd.JOS2023-10-24
08800142919213THYBLATE-V™RF Medical Co.,Ltd.JOS2023-10-24
08800142919220THYBLATE-V™RF Medical Co.,Ltd.JOS2023-10-24
08809295147382V-TipRF Medical Co.,Ltd.JOS2023-10-24
08809295147399V-TipRF Medical Co.,Ltd.JOS2023-10-24
08809295147405V-TipRF Medical Co.,Ltd.JOS2023-10-24
08809295147412V-TipRF Medical Co.,Ltd.JOS2023-10-24
08809295147429V-TipRF Medical Co.,Ltd.JOS2023-10-24
08809295147436V-TipRF Medical Co.,Ltd.JOS2023-10-24
08809295147443V-TipRF Medical Co.,Ltd.JOS2023-10-24
08809295147450V-TipRF Medical Co.,Ltd.JOS2023-10-24
08809295147467V-TipRF Medical Co.,Ltd.JOS2023-10-24
08809295147474V-TipRF Medical Co.,Ltd.JOS2023-10-24
08809295147481V-TipRF Medical Co.,Ltd.JOS2023-10-24