FDA.reportPublic FDA data

1-Button Fingerswitch Handpiece

Primary DI
00841494106638
Brand
1-Button Fingerswitch Handpiece
Company
Ellman International
Model
XKO1
Catalog number
XKO1
Device description
FSHP FOR EMC ONE-BUTTON,1/16" & 3/32"
Published
2016-09-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
00841494106638PackageGS12In Commercial Distribution
00841494106621PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841494106638008414941066388414941066380841494106638
00841494106621008414941066218414941066210841494106621

GMDN Terms#

Term, Definition table
TermDefinition
Electrosurgical handpiece, reusableA hand-held component of an electrosurgical system intended to provide an electrical connection between the system generator and a detachable electrode at its distal end, enabling the surgeon controlled manipulation of the electrode during surgery; the electrode is not included. The device is typically in the form of a pen with permanently attached cables for connection to the generator; it is not intended for use during argon-enhanced electrosurgery. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
079095245
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10841494101807RF ANGLED SUCTION COAGULATORHD42HD422016-09-21
10841494105133FRIGI-DENTEFD140ACSEFD140ACS2016-09-21
00841494106607IEC 1-Buttom Fingerswitch HandpieceIEC-X1FHPAIEC-X1FHPA2016-09-19
008414941066143-BUTTON FingerSwitch BLADE HandpieceIEC-X3FHPBIEC-X3FHPB2016-09-21
10841494103436HANDPIECEIEC-XLP1IEC-XLP12016-09-21
00841494106720IEC FOOT-CONTROLLED HPIEC-XHP1IEC-XHP12016-09-21
00841494106645MicroInsulated Needle HandpieceXH136XH1362016-09-21
00841494106652MicroInsualted Needle HandpieceIEC-XH136IEC-XH1362016-09-21
10841494104464RODIN MICROSURGERY HANDPIECEXRHPXRHP2016-09-21
00841494106669RODIN MICROSURGERY HANDPIECEIEC-XRHPCIEC-XRHPC2016-09-21

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
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08809295147481V-TipRF Medical Co.,Ltd.JOS2023-10-24