FDA.reportPublic FDA data

DOUBLEFLO

Primary DI
03661379200414
Brand
DOUBLEFLO
Company
HEMODIA
Model
A
Catalog number
72205357
Device description
FOOTSWITCH - WIRED
Published
2022-08-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
HRXArthroscope

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRXArthroscopeOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K203480000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K203480000DOUBLEFLO systemHemodia Sas2021-04-05HRX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03661379200414PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03661379200414036613792004143661379200414

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
381957786
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03661379266045DOUBLEFLOFC1722057762025-10-06
03661379239056DOUBLEFLOB172205776F2023-09-29
03661379195994DOUBLEFLOA722053592022-08-29
03661379196007DOUBLEFOA722053602021-04-13
03661379196069DOUBLEFLOA722053662021-04-13
03661379196014DOUBLEFLOA722053612023-03-22
03661379196021DOUBLEFLOA722053622023-03-22
03661379196038DOUBLEFLOA722053632023-03-22
03661379196045DOUBLEFLOA722053642023-03-22
03661379196052DOUBLEFLOA722053652023-03-22
03661379196076DOUBLEFLOA722053672023-03-22
03661379196083DOUBLEFLOA722053682023-03-22
03661379196090DOUBLEFLOA722053692023-03-22
03661379196113DOUBLEFLOA722053712023-03-22
03661379223055DOUBLEFLOA722057722023-01-25
23661379223059DOUBLEFLOA722057722023-01-25
03661379223062DOUBLEFLOA722057732023-01-25
03661379223079DOUBLEFLOA722057742023-01-25
03661379223086DOUBLEFLOA722057652023-01-25
03661379211748DOUBLEFLOB1722057762023-03-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809695579813Trocar Needle (Working Channel)GS Medical Co., Ltd.HRX2026-07-27
08809695579820Bevel Needle (Working Channel)GS Medical Co., Ltd.HRX2026-07-27
00190776422059MillenniumAvalign Technologies, Inc.HRX2026-07-24
00190776422066MillenniumAvalign Technologies, Inc.HRX2026-07-24
10810004821085Spinal Needle SetCLARUS MEDICAL, LLCHRX2026-06-23
10810004821146Curved Cannula SetCLARUS MEDICAL, LLCHRX2026-06-23
00810004821101Digital SpineScope EndoscopeCLARUS MEDICAL, LLCHRX2026-06-22
10810004821122Spinal Introducer SetCLARUS MEDICAL, LLCHRX2026-06-22
00846338001209IEC BiPolar Cable, DisposableELLIQUENCE, LLCHRX2026-06-03
00846338001230Bipolar CableELLIQUENCE, LLCHRX2026-06-03
00846338001247Bipolar Cable - 2 Flat ProngsELLIQUENCE, LLCHRX2026-06-03
00846338001537Bipolar Cable - 2 Flat ProngsELLIQUENCE, LLCHRX2026-06-03
00846338001582IEC Power Cord 110vELLIQUENCE, LLCHRX2026-06-03
00846338001605IEC Power Cord 220v ANZ PlugELLIQUENCE, LLCHRX2026-06-03
00846338001612IEC Power Cord 220v EuropeELLIQUENCE, LLCHRX2026-06-03
00846338001629IEC Power Cord U.K. 220vELLIQUENCE, LLCHRX2026-06-03
00846338007140BiPolar Cable, DisposableELLIQUENCE, LLCHRX2026-06-02
00846338005146Neutral PlateELLIQUENCE, LLCHRX2026-06-01
00846338005320Needle PunchELLIQUENCE, LLCHRX2026-06-01
10845854035559E9000Conmed CorporationHRX2026-03-24
07613327601695Connected OR HubSTRYKER CORPORATIONHRX2025-06-04
07613327601701SDC4K Information Management SystemSTRYKER CORPORATIONHRX2025-06-04
07613327638226OmnicurveSTRYKER CORPORATIONHRX2024-09-03
07613327638233OmnicurveSTRYKER CORPORATIONHRX2024-09-03
07613327638240OmnicurveSTRYKER CORPORATIONHRX2024-09-03
07613327638257OmnicurveSTRYKER CORPORATIONHRX2024-09-03
07613327638431OmnicurveSTRYKER CORPORATIONHRX2024-09-03
07613327638448OmnicurveSTRYKER CORPORATIONHRX2024-09-03
B235MDK00020mild Device KitSTRYKER CORPORATIONHRX2024-06-19
08800038059313SYNTH™ STANDARDIMEDICOM CO., LTD.HRX2024-03-25