FDA.reportPublic FDA data

ABC

Primary DI
10653405002604
Brand
ABC
Company
Conmed Corporation
Model
130345
Catalog number
130345
Device description
ABC HANDPIECE 45° Footswitching Handpiece
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
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
20653405002601PackageGS110In Commercial Distribution
10653405002604PrimaryGS10
00653405002607Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2065340500260120653405002601
1065340500260410653405002604
00653405002607006534050026076534050026070653405002607

GMDN Terms#

Term, Definition table
TermDefinition
Inert gas-enhanced open-surgery electrosurgical handpiece/electrodeAn invasive, rigid, hand-held component of an inert gas-enhanced electrosurgical system intended to deliver electrosurgical current within a stream of inert gas [e.g., argon (Ar), helium (He)] directly to tissues for cutting/coagulation during open surgery. It is a handpiece with an included electrode typically in the form of a pen with controls (or controlled via a foot-switch). It includes a coaxial arrangement of a monopolar electrode within a gas delivery sleeve. This is a single-use 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

Contacts#

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

Regulatory Flags#

DUNS number
071595540
Device count
10
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
20653405990908GENESYS™ CrossFT™CFBC-4502RCFBC-4502R2026-07-31
20653405990915GENESYS™ CrossFT™CFBC-4503RCFBC-4503R2026-07-31
20653405990922GENESYS™ CrossFT™CFBC-5502RCFBC-5502R2026-07-31
20653405990939GENESYS™ CrossFT™CFBC-5503RCFBC-5503R2026-07-31
20653405990946GENESYS™ CrossFT™CFBC-6502RCFBC-6502R2026-07-31
20653405990953GENESYS™ CrossFT™CFBC-6503RCFBC-6503R2026-07-31
10653405000242YANKAUER003447000344702016-09-24
10845854035559E9000E9015E90152026-03-24
20653405008559CONMED60-0824-00160-0824-0012016-09-24
30653405003230CONMED1380111380112016-09-24
30653405003247CONMED1380121380122016-09-24
30653405058230AER DEFENSE60-8084-00160-8084-0012016-09-24
30845854655492PlumeSafe® X5™PX5-1354-22PX5-1354-222026-07-23
20845854042004Y-KNOTYH01YH012015-10-24
20845854042028Y-KNOTYH02YH022015-10-24
10845854087534Infinity™QTSLQTSL2026-06-10
10845854087541Infinity™QTSRQTSR2026-06-10
10845854087558Infinity™RDBHRDBH2026-06-10
20653405990328Infinity™QTCRQTCR2026-06-10
20653405990366Infinity™ADB-0808ADB-08082026-06-10

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
20653405036019ABCConmed CorporationHAM2023-10-11
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
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