Cadwell Disposable Flush Tip Monopolar Probe

GUDID 10840067101824

CADWELL INDUSTRIES, INC.

Nerve-locating probe, single-use Nerve-locating system probe, single-use Nerve-locating system probe, single-use Nerve-locating system probe, single-use Nerve-locating system probe, single-use Nerve-locating system probe, single-use Nerve-locating system probe, single-use Nerve-locating system probe, single-use Nerve-locating system probe, single-use Nerve-locating system probe, single-use Nerve-locating system probe, single-use Nerve-locating system probe, single-use Nerve-locating system probe, single-use Nerve-locating system probe, single-use Nerve-locating system probe, single-use Nerve-locating system probe, single-use Nerve-locating system probe, single-use Nerve-locating system probe, single-use Nerve-locating system probe, single-use Nerve-locating system probe, single-use Nerve-locating system probe, single-use Nerve-locating system probe, single-use Nerve-locating system probe, single-use Nerve-locating system probe, single-use Nerve-locating system probe, single-use Nerve-locating system probe, single-use Nerve-locating system probe, single-use Nerve-locating system probe, single-use
Primary Device ID10840067101824
NIH Device Record Key5ddbe3c1-02e0-4749-8e38-fd3faea3a5f6
Commercial Distribution StatusIn Commercial Distribution
Brand NameCadwell Disposable Flush Tip Monopolar Probe
Version Model Number302426-000
Company DUNS098554157
Company NameCADWELL INDUSTRIES, INC.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(509)735-6481
Emailapplications@cadwell.com
Phone+1(509)735-6481
Emailapplications@cadwell.com
Phone+1(509)735-6481
Emailapplications@cadwell.com
Phone+1(509)735-6481
Emailapplications@cadwell.com
Phone+1(509)735-6481
Emailapplications@cadwell.com
Phone+1(509)735-6481
Emailapplications@cadwell.com
Phone+1(509)735-6481
Emailapplications@cadwell.com
Phone+1(509)735-6481
Emailapplications@cadwell.com
Phone+1(509)735-6481
Emailapplications@cadwell.com
Phone+1(509)735-6481
Emailapplications@cadwell.com
Phone+1(509)735-6481
Emailapplications@cadwell.com
Phone+1(509)735-6481
Emailapplications@cadwell.com
Phone+1(509)735-6481
Emailapplications@cadwell.com
Phone+1(509)735-6481
Emailapplications@cadwell.com
Phone+1(509)735-6481
Emailapplications@cadwell.com
Phone+1(509)735-6481
Emailapplications@cadwell.com
Phone+1(509)735-6481
Emailapplications@cadwell.com
Phone+1(509)735-6481
Emailapplications@cadwell.com
Phone+1(509)735-6481
Emailapplications@cadwell.com
Phone+1(509)735-6481
Emailapplications@cadwell.com
Phone+1(509)735-6481
Emailapplications@cadwell.com
Phone+1(509)735-6481
Emailapplications@cadwell.com
Phone+1(509)735-6481
Emailapplications@cadwell.com
Phone+1(509)735-6481
Emailapplications@cadwell.com
Phone+1(509)735-6481
Emailapplications@cadwell.com
Phone+1(509)735-6481
Emailapplications@cadwell.com
Phone+1(509)735-6481
Emailapplications@cadwell.com
Phone+1(509)735-6481
Emailapplications@cadwell.com

Device Dimensions

Length90 Millimeter
Length90 Millimeter
Length90 Millimeter
Length90 Millimeter
Length90 Millimeter
Length90 Millimeter
Length90 Millimeter
Length90 Millimeter
Length90 Millimeter
Length90 Millimeter
Length90 Millimeter
Length90 Millimeter
Length90 Millimeter
Length90 Millimeter
Length90 Millimeter
Length90 Millimeter
Length90 Millimeter
Length90 Millimeter
Length90 Millimeter
Length90 Millimeter
Length90 Millimeter
Length90 Millimeter
Length90 Millimeter
Length90 Millimeter
Length90 Millimeter
Length90 Millimeter
Length90 Millimeter
Length90 Millimeter

Operating and Storage Conditions

Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100840067101827 [Primary]
GS110840067101824 [Package]
Contains: 00840067101827
Package: Box [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ETNSTIMULATOR, NERVE
GXZELECTRODE, NEEDLE

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

[10840067101824]

Ethylene Oxide

[10840067101824]

Ethylene Oxide

[10840067101824]

Ethylene Oxide

[10840067101824]

Ethylene Oxide

[10840067101824]

Ethylene Oxide

[10840067101824]

Ethylene Oxide

[10840067101824]

Ethylene Oxide

[10840067101824]

Ethylene Oxide

[10840067101824]

Ethylene Oxide

[10840067101824]

Ethylene Oxide

[10840067101824]

Ethylene Oxide

[10840067101824]

Ethylene Oxide

[10840067101824]

Ethylene Oxide

[10840067101824]

Ethylene Oxide

[10840067101824]

Ethylene Oxide

[10840067101824]

Ethylene Oxide

[10840067101824]

Ethylene Oxide

[10840067101824]

Ethylene Oxide

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-02-14
Device Publish Date2016-09-05

Devices Manufactured by CADWELL INDUSTRIES, INC.

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00840067102909 - Cadwell Guiardian2024-03-12 ES-10 Electrical Stimulator
00840067102916 - Cadwell Guiardian2024-03-12 SMX-32 Direct Cortical Mapping
00840067103609 - Cadwell Guiardian2024-03-12 AVX Auditory and Visual Stimulator
10840067101411 - Cadwell Disposable Disc Electrodes2024-01-09
00840067103890 - Cadwell2022-10-03 Ring Electrode with 20in lead attached length
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