FDA.reportPublic FDA data

ASSI

Primary DI
00841645103974
Brand
ASSI
Company
ACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORPORATION
Model
AC2621
Device description
Dispersive Wristlet (Grounding)For Polarmate II
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
ODRElectrosurgical Patient Return Electrode

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ODRElectrosurgical Patient Return ElectrodeGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841645103974PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841645103974008416451039748416451039740841645103974

GMDN Terms#

Term, Definition table
TermDefinition
Electrosurgical return electrode, reusableA dispersive conductor intended to be fastened to a patient and connected to an electrosurgical/radio-frequency ablation system generator, to allow return of electrical current from the patient to the generator during an electrosurgical procedure. It has a large surface area and is fastened to the patient's body typically where the greatest surface area can be covered in closest proximity to the surgical site. It may be designed with permanently attached cables. 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
00841494108434EXTRA-LARGE GROUNDING PADCynosure, LLCODR2020-01-31
10841494108431EXTRA-LARGE GROUNDING PAD, 25 PCSCynosure, LLCODR2020-01-31
B3702613910Cameron-MillerCAMERON-MILLER INCODR2017-02-11
00841494107130Neutral PadCynosure, LLCODR2017-01-30
GYNX218091Patient Dispercive PadGYNEX CORPORATIONODR2016-10-10
GYNX337141Patient Dispersive PadGYNEX CORPORATIONODR2016-10-10
GYNX60101Patient Dispersive PadGYNEX CORPORATIONODR2016-10-10
00841494103484IEC NEUTRAL PLATECynosure, LLCODR2016-09-21
00841494105167IEC NEUTRAL PADCynosure, LLCODR2016-09-21
00841494105273NEUTRAL PADCynosure, LLCODR2016-09-21