FDA.reportPublic FDA data

Compumedics Quik-Cap

Primary DI
09342451004673
Brand
Compumedics Quik-Cap
Company
COMPUMEDICS LIMITED
Model
Quik-Cap Neoprene Flexnet - SynAmps 2/RT 128 Ch In
Catalog number
8035-0019-01
Device description
Quik-Cap Neoprene Flexnet - SynAmps 2/RT 128 Ch Infant
Published
2026-03-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GXYElectrode, Cutaneous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GXYElectrode, CutaneousNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K000865000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K000865000QUIK-CAPNeuroscan2000-04-18GXY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09342451004673PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09342451004673093424510046739342451004673

GMDN Terms#

Term, Definition table
TermDefinition
Electroencephalographic electrode cap, single-useAn array of analytical scalp electrodes preconfigured within a head-worn device designed for the rapid placement and appropriate positioning of the scalp electrodes during electroencephalography (EEG). It typically consists of a cap-like device with integrated scalp electrodes, and shielded lead wires that terminate into a connector that mates with a separate cable. The device eliminates the need to glue or paste individual electrodes to the patient’s scalp. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+61384207386support@compumedics.com.au
1-877-294-1346support@compumedicsusa.com

Regulatory Flags#

DUNS number
753750967
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09342451002433Compumedics CurryCURRY 98238-0044-012026-03-12
09342451002655Compumedics SomfitSomfit8037-0001-002026-03-12
09342451002662Compumedics SomfitSomfit Charger8037-0101-002026-03-12
09342451002747Compumedics FalconFalcon HST8036-0002-022026-03-12
09342451002754Compumedics FalconFalcon HST8036-0003-012026-03-12
09342451002785Compumedics FalconFalcon HST9036-0001-022026-03-12
09342451002822Compumedics SomfitSomfit9037-0003-002026-03-12
09342451002860Compumedics SomfitSomfit9037-0013-002026-03-12
09342451003416Compumedics Quik-GelQuik-Gel Electrolyte920000172026-03-12
09342451003423Compumedics Quik-GelQuik-Gel Electrolyte920000162026-03-12
09342451003430Compumedics Quik-GelQuik-Gel Electrolyte920000152026-03-12
09342451003447Compumedics Quik-GelQuik-Gel Electrolyte920000142026-03-12
09342451007063Compumedics Somfit DSomfit D9037-0022-002026-03-12
09342451004772Compumedics Quik-CapQuik-Cap Neoprene Flexnet - SynAmps 2/RT 128 Ch La8035-0007-012026-03-03
09342451003904Compumedics Quik-CapQuik-Cap Hydrocell Array - SynAmps 2/RT 64 Ch Medi8035-0164-012026-03-02
09342451003980Compumedics Quik-CapQuik-Cap Neoprene Flexnet - Grael 128 Ch Medium8035-0154-012026-03-02
09342451003997Compumedics Quik-CapQuik-Cap Neoprene Flexnet - Grael 64 Ch Medium8035-0153-012026-03-02
09342451004000Compumedics Quik-CapQuik-Cap Neoprene Flexnet - SynAmps 2/RT 256 Ch Me8035-0151-012026-03-02
09342451004017Compumedics Quik-CapQuik-Cap Neoprene Flexnet - SynAmps 2/RT 128 Ch Me8035-0150-012026-03-02
09342451004024Compumedics Quik-CapQuik-Cap Neoprene Flexnet - SynAmps 2/RT 64 Ch Med8035-0149-012026-03-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00817717023105SENSADERMVision Quest Industries IncorporatedGXY2026-10-23
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00817717023136SENSADERMVision Quest Industries IncorporatedGXY2026-10-23
00851913006296UltraStim Wire FoamAXELGAARD MANUFACTURING CO., LTD.GXY2026-10-21
00382830063821NatusXLTEKGXY2026-10-15
00382830063838NatusXLTEKGXY2026-10-15
00382830063845NatusXLTEKGXY2026-10-15
00382830063852NatusXLTEKGXY2026-10-15
00382830063869NatusXLTEKGXY2026-10-15
00382830063876NatusXLTEKGXY2026-10-15
00382830063883NatusXLTEKGXY2026-10-15
00382830063890NatusXLTEKGXY2026-10-15
00382830063906NatusXLTEKGXY2026-10-15
00382830063913NatusXLTEKGXY2026-10-15
00382830063920NatusXLTEKGXY2026-10-15
00382830063937NatusXLTEKGXY2026-10-15
06973602731105Premium Gel White Fabri ElectrodesTOP-RANK HEALTH CARE CO., LTD.GXY2026-10-12
06973602731112Premium Gel White Fabri ElectrodesTOP-RANK HEALTH CARE CO., LTD.GXY2026-10-12
06973602731129Premium Gel White Fabri ElectrodesTOP-RANK HEALTH CARE CO., LTD.GXY2026-10-12
00850080988718AUVONUAN HEALTHCARE LIMITEDGXY2026-10-08
00810200390265KSK.S. CHOI, CORPORATIONGXY2026-09-22
00810200390272AcuZoneK.S. CHOI, CORPORATIONGXY2026-09-22
00860014334320PASCALL SYSTEMS, INC.PASCALL SYSTEMS, INC.GXY2026-09-04
08720791379131EZ1020Technomed Engineering B.V.GXY2026-08-07
08720791379148EZ1020Technomed Engineering B.V.GXY2026-08-07
08720791379155EZ1020Technomed Engineering B.V.GXY2026-08-07
08720791379162EZ1020Technomed Engineering B.V.GXY2026-08-07
08720791379179EZ1020Technomed Engineering B.V.GXY2026-08-07
08720791379209EZ1020Technomed Engineering B.V.GXY2026-08-07