FDA.reportPublic FDA data

ABC

Primary DI
20653405036019
Brand
ABC
Company
Conmed Corporation
Model
130500
Catalog number
130500
Device description
ABC ELECTROSURGICAL HANDPIECE
Published
2023-10-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HAMAPPARATUS, ELECTROSURGICAL

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
40653405036013Direct MarkingGS10
30653405036016PreviousGS10
20653405036019PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4065340503601340653405036013
3065340503601630653405036016
2065340503601920653405036019

GMDN Terms#

Term, Definition table
TermDefinition
Foot-switch, electricalAn electrically-powered pedal used by an operator of a medical device to regulate the activation and/or intensity of a parent device (e.g., electrosurgical system generator, laser, ophthalmic examination unit, dental drill/saw system control unit) to which it is connected, typically via an electrical cable. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity5 Percent (%) Relative Humidity70 Percent (%) Relative Humidity
Storage Environment Temperature10 Degrees Celsius32 Degrees Celsius
Storage Environment Temperature50 Degrees Fahrenheit90 Degrees Fahrenheit

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(866)426-6633CustomerExperience@conmed.com

Regulatory Flags#

DUNS number
071595540
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10845854051399AirSealiAS8-dViAS8-dV2021-08-22
10845854084137AirSeal®iAS8-dVLiAS8-dVL2023-01-06
10845854013137QUICKLATCHQL4300QL43002020-12-10
10845854031841CONMEDT2531T25312020-12-10
10845854036204POWERPROPRO6185PRO61852023-09-01
20845854061807SnapEvacSNAPEVAC20SNAPEVAC202020-06-06
30653405011907EXCEL60-6050-00160-6050-0012016-09-24
30653405988346Argo KnotlessK55RTAPK55RTAP2023-01-13
30653405988360Argo KnotlessK475RTAPK475RTAP2023-01-13
10845854032619CROSSFTTFT-45MTFT-45M2021-01-19
10845854032633CROSSFTTFT-55MTFT-55M2021-01-19
10845854032657CROSSFTTFT-65MTFT-65M2021-01-19
10653405004646ELECTROLASE HYFRECATOR7-100-8BX7-100-8BX2016-09-24
10653405013785THERMOGARD7-3847-3842016-09-24
10845854650134THERMOGARD7-3827-3822022-09-21
20653405051906Precisor0008520008522016-09-24
20653405051920Precisor0008540008542016-09-24
30653405046800BiCap SuperconductorBP-10300ABP-10300A2016-09-24
30653405046992BiCap SuperconductorBP-7300ABP-7300A2016-09-24
30653405047005BiCap SuperconductorBP-5200ABP-5200A2016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841019117552KirwanKIRWAN SURGICAL PRODUCTS LLCHAM2025-04-07
00841019117569KirwanKIRWAN SURGICAL PRODUCTS LLCHAM2025-04-07
00841019117576KirwanKIRWAN SURGICAL PRODUCTS LLCHAM2025-04-07
10841019117559KirwanKIRWAN SURGICAL PRODUCTS LLCHAM2025-04-07
10841019117566KirwanKIRWAN SURGICAL PRODUCTS LLCHAM2025-04-07
10841019117573KirwanKIRWAN SURGICAL PRODUCTS LLCHAM2025-04-07
00653405002102CONMEDConmed CorporationHAM2023-11-30
20653405002106CONMEDConmed CorporationHAM2023-11-30
14026704662118PILLINGTELEFLEX INCORPORATEDHAM2019-06-03
34026704662112PILLINGTELEFLEX INCORPORATEDHAM2019-06-03
19555240400854ITL Essential Laparoscopic Quiver ExtendableITL ASIA PACIFIC SDN. BHD.HAM2019-05-25
19555240401141ITL Essential Standard QuiverITL ASIA PACIFIC SDN. BHD.HAM2019-05-25
19555240400946ITL Essential Laparoscopic Quiver ExtendableITL ASIA PACIFIC SDN. BHD.HAM2019-05-25
19555240400748ITL Essential Standard QuiverITL ASIA PACIFIC SDN. BHD.HAM2019-05-25
14026704662125WECKTELEFLEX INCORPORATEDHAM2019-05-08
24026704662122WECKTELEFLEX INCORPORATEDHAM2019-05-08
20888937014413LEEP Disposable Universal ElectrodesCoopersurgical, Inc.HAM2016-10-05
24026704599879WECKTELEFLEX INCORPORATEDHAM2016-09-30
04026704599875WeckTELEFLEX INCORPORATEDHAM2016-09-30
10653405002475ABCConmed CorporationHAM2016-09-24
10653405002604ABCConmed CorporationHAM2016-09-24
30653405036016ABCConmed CorporationHAM2016-09-24
30653405002103CONMEDConmed CorporationHAM2016-09-24
20653405002472ABCConmed CorporationHAM2016-09-24
20653405002601ABCConmed CorporationHAM2016-09-24
40653405036013ABCConmed CorporationHAM2016-09-24
B3964500140ESIFTT MEDICAL, INC.HAM2016-09-20
B3964500160ESIFTT MEDICAL, INC.HAM2016-09-20
B3964500180ESIFTT MEDICAL, INC.HAM2016-09-20
B3964500200ESIFTT MEDICAL, INC.HAM2016-09-20