FDA.reportPublic FDA data

Disposable Bipolar Focused Irrigating Forceps, 7", 1.5mm Straight Tips, Box of 5

Primary DI
10817489024857
Brand
Disposable Bipolar Focused Irrigating Forceps, 7", 1.5mm Straight Tips, Box of 5
Company
KATALYST SURGICAL LLC
Model
DKIF7-15S
Device description
Disposable Bipolar Focused Irrigating Forceps, 7", 1.5mm Straight Tips, Box of 5
Published
2017-03-22
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
GEIElectrosurgical, Cutting & Coagulation & Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEIElectrosurgical, Cutting & Coagulation & AccessoriesGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10817489024857PrimaryGS10
00817489024850Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081748902485710817489024857
00817489024850008174890248508174890248500817489024850

GMDN Terms#

Term, Definition table
TermDefinition
Open-surgery electrosurgical handpiece/electrode, bipolar, single-useA sterile rigid combined electrosurgical handpiece and bipolar electrode, intended to deliver electrosurgical current from a system generator directly to tissues for cutting/coagulation during an open surgical procedure. It is available in a variety of forms (e.g., pen, pistol-shaped forceps, pincer-shaped forceps, scissors) and may also include irrigation, aspiration, lavage and/or surgical plume (smoke) evacuation features to support its primary electrosurgical function. This is a single-use device.

Regulatory Flags#

DUNS number
007883297
Device count
5
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
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
1084009621334527ga Stiff MultiFlex Inverted Extendable Laser Probe, Iridex ConnectorV6520E-27A2020-10-27
1084009621335227ga Stiff MultiFlex Inverted Extendable Laser Probe, Alcon ConnectorV6520E-27B2020-10-27
1084009621336927ga Stiff MultiFlex Inverted Extendable Laser Probe, Quantel ConnectorV6520E-27C2020-10-27
1084009621337627ga Stiff MultiFlex Inverted Extendable Laser Probe, Nidek ConnectorV6520E-27E2020-10-27
1084009621338327ga Stiff MultiFlex Inverted Extendable Laser Probe, Dorc ConnectorV6520E-27J2020-10-27
1084009621395625ga Illuminated MultiFlex™ Laser Probe, DORC ConnectorV6351-25JR2021-01-07
0084009620650023ga ISOCLEAN™ Micro Tying Forceps Gold3850S-M23G2020-05-27
0084009620676023ga ISOCLEAN™ Curved Iridectomy Scissors, Straight Shaft, Gold6850C-M23G2020-06-01
00840096208276Revolver Universal ConnectorRLP-A2020-06-08
00840096208283Constellation Illumination AdapterRLP-Q2020-06-10
00840096208290Stellaris Illumination AdapterRLP-S2020-06-10
00840096208306DORC Illumination AdapterRLP-U2020-06-10
00840096208313Short 19ga Needle Illumination AdapterRLP-V2020-06-10
0084009621284623ga ISOCLEAN™ Curved Iridectomy Scissors, Straight Shaft6850C-M232020-06-18
00840096207613DEX TIPS™ Universal Slim HandleCVO-Handle2020-06-08
10817489024536Revolver FiberV66002019-07-17
10817489024833Disposable Bipolar Focused Irrigating Forceps, 7", 0.5mm Straight Tips, Box of 5DKIF7-05S2017-03-22
10817489024840Disposable Bipolar Focused Irrigating Forceps, 7", 1.0mm Straight Tips, Box of 5DKIF7-10S2017-03-22
10817489024864Disposable Bipolar Focused Irrigating Forceps, 8", 0.5mm Straight Tips, Box of 5DKIF8-05S2017-03-22
10817489024871Disposable Bipolar Focused Irrigating Forceps, 8", 1.0mm Straight Tips, Box of 5DKIF8-10S2017-03-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00198506091292ELMED INCORPORATEDELMED INCORPORATEDGEI2026-06-09
00198506091308ELMED INCORPORATEDELMED INCORPORATEDGEI2026-06-09
00198506091360ELMED INCORPORATEDELMED INCORPORATEDGEI2026-06-09
00198506091377ELMED INCORPORATEDELMED INCORPORATEDGEI2026-06-09
00198506091384ELMED INCORPORATEDELMED INCORPORATEDGEI2026-06-09
00198506091391ELMED INCORPORATEDELMED INCORPORATEDGEI2026-06-09
00860015792006NOVOCLEAR™ DeviceAventix Medical Inc.GEI2026-06-09
00860015792013AVENTIX® PFX SystemAventix Medical Inc.GEI2026-06-09
00685447020677RFP-100A™ RF Puncture GeneratorBOSTON SCIENTIFIC CORPORATIONGEI2026-06-08
08800042706159Artisential Monopolar SpatulaLIVSMEDGEI2026-06-05
00840319759042Hayden MedicalHayden Medical, Inc.GEI2026-06-04
00840319759059Hayden MedicalHayden Medical, Inc.GEI2026-06-04
00840319759066Hayden MedicalHayden Medical, Inc.GEI2026-06-04
00840319759073Hayden MedicalHayden Medical, Inc.GEI2026-06-04
08809306764072VIVA RF ElectrodeSTARMED CO.,LTDGEI2026-06-04
08809306764089VIVA RF ElectrodeSTARMED CO.,LTDGEI2026-06-04
08809306764133VIVA RF ElectrodeSTARMED CO.,LTDGEI2026-06-04
08809306764140VIVA RF ElectrodeSTARMED CO.,LTDGEI2026-06-04
08809306764157VIVA RF ElectrodeSTARMED CO.,LTDGEI2026-06-04
08809306764164VIVA RF ElectrodeSTARMED CO.,LTDGEI2026-06-04
08809306764171VIVA RF ElectrodeSTARMED CO.,LTDGEI2026-06-04
08809306764188VIVA RF ElectrodeSTARMED CO.,LTDGEI2026-06-04
00198506091261ELMED INCORPORATEDELMED INCORPORATEDGEI2026-06-03
00846338001209IEC BiPolar Cable, DisposableELLIQUENCE, LLCGEI2026-06-03
00846338001230Bipolar CableELLIQUENCE, LLCGEI2026-06-03
00846338001247Bipolar Cable - 2 Flat ProngsELLIQUENCE, LLCGEI2026-06-03
00846338001537Bipolar Cable - 2 Flat ProngsELLIQUENCE, LLCGEI2026-06-03
00846338001582IEC Power Cord 110vELLIQUENCE, LLCGEI2026-06-03
00846338001605IEC Power Cord 220v ANZ PlugELLIQUENCE, LLCGEI2026-06-03
00846338001612IEC Power Cord 220v EuropeELLIQUENCE, LLCGEI2026-06-03