FDA.reportPublic FDA data

Cadwell Patented Multi-Stage Clip

Primary DI
00840067100158
Brand
Cadwell Patented Multi-Stage Clip
Company
CADWELL INDUSTRIES, INC.
Model
302775-200
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
IKDCABLE, ELECTRODE

Product Code Classifications

CodeDeviceSpecialtyClass
IKDCable, ElectrodePhysical Medicine2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840067103104PackageGS110In Commercial Distribution
00840067103111PackageGS1150In Commercial Distribution
00840067100158PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840067103104008400671031048400671031040840067103104
00840067103111008400671031118400671031110840067103111
00840067100158008400671001588400671001580840067100158

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.

Device Sizes

TypeValueUnit
Length72Inch

Sterilization Methods

Method
Ethylene Oxide

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
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company

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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
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00840067102961Cadwell302767-2002024-06-30
00840067104040Cadwell302055-2002024-06-30
00840067104057Cadwell302058-2002024-06-30

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