Cadwell Disposable Double Ball-Tip Probe

GUDID 00840067102480

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 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

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

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

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

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