Cadwell Disposable Double Ball-Tip Probe

GUDID 00840067102480

CADWELL INDUSTRIES, INC.

Nerve-locating probe, single-use

Primary Device ID	00840067102480
NIH Device Record Key	b73675b0-971f-4542-9a12-d8bd267d9a87
Commercial Distribution Status	In Commercial Distribution
Brand Name	Cadwell Disposable Double Ball-Tip Probe
Version Model Number	302431-000-030
Company DUNS	098554157
Company Name	CADWELL INDUSTRIES, INC.
Device Count	1
DM Exempt	true
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	true
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	true
RX Perscription	true
OTC Over-The-Counter	false

Customer Support Contacts

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

Device Dimensions

Length	30 Millimeter
Length	30 Millimeter
Length	30 Millimeter
Length	30 Millimeter
Length	30 Millimeter
Length	30 Millimeter
Length	30 Millimeter
Length	30 Millimeter
Length	30 Millimeter
Length	30 Millimeter
Length	30 Millimeter
Length	30 Millimeter
Length	30 Millimeter
Length	30 Millimeter
Length	30 Millimeter
Length	30 Millimeter
Length	30 Millimeter
Length	30 Millimeter
Length	30 Millimeter
Length	30 Millimeter
Length	30 Millimeter
Length	30 Millimeter
Length	30 Millimeter
Length	30 Millimeter
Length	30 Millimeter
Length	30 Millimeter
Length	30 Millimeter
Length	30 Millimeter
Length	30 Millimeter
Length	30 Millimeter
Length	30 Millimeter
Length	30 Millimeter
Length	30 Millimeter
Length	30 Millimeter
Length	30 Millimeter
Length	30 Millimeter
Length	30 Millimeter
Length	30 Millimeter
Length	30 Millimeter
Length	30 Millimeter
Length	30 Millimeter
Length	30 Millimeter
Length	30 Millimeter
Length	30 Millimeter
Length	30 Millimeter
Length	30 Millimeter
Length	30 Millimeter
Length	30 Millimeter
Length	30 Millimeter
Length	30 Millimeter
Length	30 Millimeter
Length	30 Millimeter
Length	30 Millimeter
Length	30 Millimeter
Length	30 Millimeter
Length	30 Millimeter
Length	30 Millimeter
Length	30 Millimeter
Length	30 Millimeter
Length	30 Millimeter
Length	30 Millimeter

Operating and Storage Conditions

Storage Environment Temperature	Between -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -10 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840067102480 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K103128
Premarket Notification: K112426

FDA Product Code

ETN	STIMULATOR, NERVE
GXZ	ELECTRODE, NEEDLE

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

[00840067102480]

Ethylene Oxide

[00840067102480]

Ethylene Oxide

[00840067102480]

Ethylene Oxide

[00840067102480]

Ethylene Oxide

[00840067102480]

Ethylene Oxide

[00840067102480]

Ethylene Oxide

[00840067102480]

Ethylene Oxide

[00840067102480]

Ethylene Oxide

[00840067102480]

Ethylene Oxide

[00840067102480]

Ethylene Oxide

[00840067102480]

Ethylene Oxide

[00840067102480]

Ethylene Oxide

[00840067102480]

Ethylene Oxide

[00840067102480]

Ethylene Oxide

[00840067102480]

Ethylene Oxide

[00840067102480]

Ethylene Oxide

[00840067102480]

Ethylene Oxide

[00840067102480]

Ethylene Oxide

[00840067102480]

Ethylene Oxide

[00840067102480]

Ethylene Oxide

[00840067102480]

Ethylene Oxide

[00840067102480]

Ethylene Oxide

[00840067102480]

Ethylene Oxide

[00840067102480]

Ethylene Oxide

[00840067102480]

Ethylene Oxide

[00840067102480]

Ethylene Oxide

[00840067102480]

Ethylene Oxide

[00840067102480]

Ethylene Oxide

[00840067102480]

Ethylene Oxide

[00840067102480]

Ethylene Oxide

[00840067102480]

Ethylene Oxide

[00840067102480]

Ethylene Oxide

[00840067102480]

Ethylene Oxide

[00840067102480]

Ethylene Oxide

[00840067102480]

Ethylene Oxide

[00840067102480]

Ethylene Oxide

[00840067102480]

Ethylene Oxide

[00840067102480]

Ethylene Oxide

[00840067102480]

Ethylene Oxide

[00840067102480]

Ethylene Oxide

[00840067102480]

Ethylene Oxide

[00840067102480]

Ethylene Oxide

[00840067102480]

Ethylene Oxide

[00840067102480]

Ethylene Oxide

[00840067102480]

Ethylene Oxide

[00840067102480]

Ethylene Oxide

[00840067102480]

Ethylene Oxide

[00840067102480]

Ethylene Oxide

[00840067102480]

Ethylene Oxide

[00840067102480]

Ethylene Oxide

[00840067102480]

Ethylene Oxide

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	4
Public Version Date	2019-02-14
Device Publish Date	2018-02-22

On-Brand Devices [Cadwell Disposable Double Ball-Tip Probe]

00840067102480	302431-000-030
00840067101902	302431-000