FDA.report

Cadwell Disposable Subdermal Needle Electrode

Primary DI
10840067101459
Brand
Cadwell Disposable Subdermal Needle Electrode
Company
CADWELL INDUSTRIES, INC.
Model
302353-000-100
Published
2016-09-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
GXZELECTRODE, NEEDLE

Product Code Classifications

CodeDeviceSpecialtyClass
GXZElectrode, NeedleNeurology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10840067101459PackageGS124In Commercial Distribution
00840067101452PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1084006710145910840067101459
00840067101452008400671014528400671014520840067101452

GMDN Terms

TermDefinition
Subdermal needle electrodeA sterile, multi-purpose electrical conductor inserted beneath the dermal layer of a patient's skin to record/monitor electrical activity (biopotentials) for physiological measurements [typically electroencephalography (EEG), electromyography (EMG), and evoked-potential) and often to provide electrical stimulation. It typically consists of thin shaft of stainless steel connected to a lead wire that terminates with a safety connector for attachment to recording/monitoring and stimulation systems. This is a single-use device.

Device Sizes

TypeValueUnit
Length2.5Meter

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature-10 Degrees Celsius50 Degrees Celsius

Sterilization Methods

Method
Ethylene Oxide

Contacts

PhoneEmail
+1(800)245-3001service@cadwell.com
+1(509)735-6481applications@cadwell.com

Regulatory Flags

DUNS number
098554157
Device count
1
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
true
Sterilization required before use
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00840067104224Cadwell190306-200-COR2026-03-02
00840067104200Cadwell190306-200-TST2026-03-01
00840067104217Cadwell190306-200-LEG2026-03-01
00840067102305Cadwell Bar302146-2002025-12-31
00840067103005Cadwell302692-2002025-12-31
00840067103029Zenith199355-2002025-12-31
00840067104132Cadwell BlueBird302501-200-0302025-12-31
00840067104156Cadwell BlueBird302501-200-0402025-12-31
00840067104170Cadwell BlueBird302501-200-0502025-12-31
00840067103555Cadwell Guardian199334-000-0082024-11-15
00840067103562Cadwell Guardian199335-000-0082024-11-15
00840067103623Cadwell Guardian199335-000-0032024-11-15
00840067103630Cadwell Guardian199334-000-0032024-11-15
00840067103982Sierra Summit190317-2002024-11-15
00840067102992Cadwell Guardian199321-2002024-08-23
10840067103996Cadwell197342-0002024-08-23
00840067102954Cadwell302768-2002024-06-30
00840067102961Cadwell302767-2002024-06-30
00840067104040Cadwell302055-2002024-06-30
00840067104057Cadwell302058-2002024-06-30

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
08720791377700InomedTechnomed Engineering B.V.GXZ2025-12-10
10816312027850Rhythmlink®RHYTHMLINK INTERNATIONAL, LLCGXZ2025-12-05
10816312027867Rhythmlink®RHYTHMLINK INTERNATIONAL, LLCGXZ2025-12-03
00816312027365Rhythmlink®RHYTHMLINK INTERNATIONAL, LLCGXZ2025-07-30
00816312027372Rhythmlink®RHYTHMLINK INTERNATIONAL, LLCGXZ2025-07-30
08720791377656CadwellTechnomed Engineering B.V.GXZ2025-05-26
08720791377670CadwellTechnomed Engineering B.V.GXZ2025-05-26
00816312027709Rhythmlink®RHYTHMLINK INTERNATIONAL, LLCGXZ2025-05-16
00816312027716Rhythmlink®RHYTHMLINK INTERNATIONAL, LLCGXZ2025-05-16
00816312027723Rhythmlink®RHYTHMLINK INTERNATIONAL, LLCGXZ2025-05-16
00816312027730Rhythmlink®RHYTHMLINK INTERNATIONAL, LLCGXZ2025-05-16
00816312027747Rhythmlink®RHYTHMLINK INTERNATIONAL, LLCGXZ2025-05-16
10816312027652Rhythmlink®RHYTHMLINK INTERNATIONAL, LLCGXZ2025-05-05
10816312027669Rhythmlink®RHYTHMLINK INTERNATIONAL, LLCGXZ2025-05-05
10841019116910KirwanKIRWAN SURGICAL PRODUCTS LLCGXZ2025-04-07
10841019122409KirwanKIRWAN SURGICAL PRODUCTS LLCGXZ2025-04-04
10841019122416KirwanKIRWAN SURGICAL PRODUCTS LLCGXZ2025-04-04
10841019122423KirwanKIRWAN SURGICAL PRODUCTS LLCGXZ2025-04-04
08720791374587NeurosignTechnomed Engineering B.V.GXZ2025-02-28
08720791374600NeurosignTechnomed Engineering B.V.GXZ2025-02-28
08720791374624NeurosignTechnomed Engineering B.V.GXZ2025-02-28
08720791374648NeurosignTechnomed Engineering B.V.GXZ2025-02-28
08720791374662NeurosignTechnomed Engineering B.V.GXZ2025-02-28
08720791374686NeurosignTechnomed Engineering B.V.GXZ2025-02-28
08720791375706CadwellTechnomed Engineering B.V.GXZ2025-02-28
08720791375720CadwellTechnomed Engineering B.V.GXZ2025-02-28
08720791375744CadwellTechnomed Engineering B.V.GXZ2025-02-28
08720791375768CadwellTechnomed Engineering B.V.GXZ2025-02-28
08720791375782CadwellTechnomed Engineering B.V.GXZ2025-02-28
10816312027515Rhythmlink®RHYTHMLINK INTERNATIONAL, LLCGXZ2025-02-26