FDA.reportPublic FDA data

Trigger-Flex Quad Pro Bipolar System

Primary DI
00846338004477
Brand
Trigger-Flex Quad Pro Bipolar System
Company
ELLIQUENCE, LLC
Model
DTFQM-39
Device description
Trigger-Flex Quad Pro Bipolar System - 39cm WL
Published
2026-05-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
00846338004477PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00846338004477008463380044778463380044770846338004477

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic electrosurgical handpiece/electrode, bipolar, single-useA sterile electrosurgical device which consists of a handpiece with mechanical and/or electrical controls, and a bipolar electrode intended to deliver electrosurgical current from a system generator directly to tissues for cutting/coagulation/ablation during endoscopic (including laparoscopic, arthroscopic) surgery, and may in addition be intended for open surgery; it is not intended for focal percutaneous ablation. It includes a long thin electrode connected to the handpiece, and may include a lumen for suction/irrigation; it is available in a variety of forms (e.g., forceps, rigid probe with controls). This is a single-use device.

Regulatory Flags#

DUNS number
019872358
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00846338003869Surgi-Max Drill16-02002026-05-11
00846338003876Surgi-Max Drill16-02012026-05-11
00846338004422Trigger-Flex Quad Pro Bipolar SystemDTFQM-132026-05-11
00846338004439Trigger-Flex Quad Pro Bipolar SystemDTFQM-342026-05-11
00846338004446Trigger-Flex Quad Pro Bipolar SystemDTFQM-352026-05-11
00846338004453Trigger-Flex Quad Pro Bipolar SystemDTFQM-362026-05-11
00846338004460Trigger-Flex Quad Pro Bipolar SystemDTFQM-382026-05-11
00846338004484Bipolar Forceps J12026-05-11
00846338004491COBBRARF-COBB/XL2026-05-11
00846338004507COBBRARF-COBB/S2026-05-11
00846338004514COBBRARF-COBB/XS2026-05-11
00846338004521Endiscope10-20162026-05-11
00846338004538Endiscope10-20172026-05-11
00846338004545Endiscope10-20182026-05-11
00846338004552Endiscope10-20192026-05-11
00846338004569Endiscope10-20242026-05-11
00846338004576Endiscope10-20252026-05-11
00846338004583Endiscope10-20262026-05-11
00846338004590Endiscope10-20272026-05-11
00846338004606Endiscope10-20282026-05-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613327693287MalisSTRYKER CORPORATIONGEI2026-02-25
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07613327556469NeptuneSTRYKER CORPORATIONGEI2025-01-30
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07613327556650NeptuneSTRYKER CORPORATIONGEI2024-12-13
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07613327548167NeptuneSTRYKER CORPORATIONGEI2024-12-10