FDA.reportPublic FDA data

Cadwell Disposable Subdermal Needle Electrode

Primary DI
10840067101442
Brand
Cadwell Disposable Subdermal Needle Electrode
Company
CADWELL INDUSTRIES, INC.
Model
302353-000-080
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
GXZELECTRODE, NEEDLE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GXZElectrode, NeedleNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10840067101442PackageGS124In Commercial Distribution
00840067101445PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084006710144210840067101442
00840067101445008400671014458400671014450840067101445

GMDN Terms#

Term, Definition table
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#

Type, Value, Unit table
TypeValueUnit
Length2Meter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-10 Degrees Celsius50 Degrees Celsius

Sterilization Methods#

Method table
Method
Ethylene Oxide

Contacts#

Phone, Email table
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 DI, Brand, Model table
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

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