FDA.report

Cascade Extender Pod

Primary DI
00840067100752
Brand
Cascade Extender Pod
Company
CADWELL INDUSTRIES, INC.
Model
199252-200
Device description
Cascade Remote Input Extender Pods, Quickconnect, 6 Meter
Published
2019-02-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
IKDCABLE, ELECTRODE

Product Code Classifications

CodeDeviceSpecialtyClass
IKDCable, ElectrodePhysical Medicine2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840067100752PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840067100752008400671007528400671007520840067100752

GMDN Terms

TermDefinition
Electromyographic needle electrode, single-useA sterile electrical conducting device designed to be inserted percutaneously into muscle or nerve tissue to detect bioelectrical signal activity. It is a needle-like device (a needle electrode with an electrical connector at the proximal end) that is connected to an electromyograph (EMG) with a dedicated cable/lead. The EMG records the electrical signals and converts them into a readable graph format; it is not primarily intended for nerve stimulation. This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(509)735-6481applications@cadwell.com

Regulatory Flags

DUNS number
098554157
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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00840067103630Cadwell Guardian199334-000-0032024-11-15
00840067103982Sierra Summit190317-2002024-11-15
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00840067102954Cadwell302768-2002024-06-30
00840067102961Cadwell302767-2002024-06-30
00840067104040Cadwell302055-2002024-06-30
00840067104057Cadwell302058-2002024-06-30

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