Cadwell Disposable Monopolar Probe

GUDID 00840067101698

CADWELL INDUSTRIES, INC.

Nerve-locating probe, single-use
Primary Device ID00840067101698
NIH Device Record Key0f590f6d-a1a9-4067-b349-b385760159f5
Commercial Distribution StatusIn Commercial Distribution
Brand NameCadwell Disposable Monopolar Probe
Version Model Number302400-000
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
GS100840067101698 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GXZELECTRODE, NEEDLE

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

[00840067101698]

Ethylene Oxide


[00840067101698]

Ethylene Oxide


[00840067101698]

Ethylene Oxide


[00840067101698]

Ethylene Oxide


[00840067101698]

Ethylene Oxide


[00840067101698]

Ethylene Oxide


[00840067101698]

Ethylene Oxide


[00840067101698]

Ethylene Oxide


[00840067101698]

Ethylene Oxide


[00840067101698]

Ethylene Oxide


[00840067101698]

Ethylene Oxide


[00840067101698]

Ethylene Oxide


[00840067101698]

Ethylene Oxide


[00840067101698]

Ethylene Oxide


[00840067101698]

Ethylene Oxide


[00840067101698]

Ethylene Oxide


[00840067101698]

Ethylene Oxide


[00840067101698]

Ethylene Oxide


Device Entry Metadata

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

On-Brand Devices [Cadwell Disposable Monopolar Probe]

10840067101855302427-000-275
10840067101848302427-000-200
10840067101831302427-000
00840067101698302400-000

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