NeuroTrace 500-02

GUDID B339500020

Neuro-Trace II Nerve Locator

NEO MEDICAL INC.

Nerve-locating system

• Primary Device ID: B339500020
• NIH Device Record Key: fbf01145-c306-4840-b384-de51006c61de
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NeuroTrace
• Version Model Number: 500-02
• Catalog Number: 500-02
• Company DUNS: 015510540
• Company Name: NEO MEDICAL INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• 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: 888-450-3334
• Email: support@neomedicalinc.com
• Phone: 888-450-3334
• Email: support@neomedicalinc.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B339500020 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K831715

FDA Product Code

• ETN: Stimulator, Nerve

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-24

On-Brand Devices [NeuroTrace]

• B33955718150: Insulated Electro-Needle for use in Regional Anesthesia, 18ga x 6.0" (152mm), Tuohy Bevel
• B33955718090: Insulated Electro-Needle for use in Regional Anesthesia, 18ga x 3.5" (89 mm), Tuohy Bevel
• B33955718055: Insulated Electro-Needle for use in Regional Anesthesia, 18ga x 2.0" (51mm), Tuohy Bevel
• B33955625040: Insulated Electro-Needle for use in Regional Anesthesia, 25ga x 1.5" (38mm) , B Bevel
• B33955623040: Insulated Electro-needle for Regional Anesthesia, 23ga x 1.5" (38mm), B Bevel
• B33955522120: Insulated Electro-needle use in Regional Anesthesia 22ga x 5.0" (127mm), Pencil Point / Whitacre
• B33955522070: Insulated Electro-needle for use in Regional Anesthesia 22ga x 3.0" (76mm) Pencil Point / Whitac
• B33955423090: Insulated Electro-Needle for use in Regional Anesthesia, 23ga x 3.5" (89mm), Short Bevel
• B33955422050: Insulated Electro-Needle for use in Regional Anesthesia, 22ga x 1.97" (50mm), Short Bevel
• B33955325040: Insulated Electro-Needle for use in Regional Anesthesia, 25ga x 1.5" (38mm), B Bevel
• B33955323040: Insulated Electro-Needle for use in Regional Anesthesia, 23ga x 1.5" (38mm), B Bevel
• B33955323020: Insulated Electro-Needle for use in Regional Anesthesia, 23ga x 0.8" (20mm), B Bevel
• B33955322120: Insulated Electro-Needle for use in Regional Anesthesia, 22ga x 5.0" (127mm), B Bevel
• B33955322075: Insulated Electro-Needle for use in Regional Anesthesia, 22ga x 3.0" (76mm), B Bevel
• B33955223070: Insulated Electro-Needle for use in Regional Anesthesia, 23ga x 3.0" (76mm), Pencil Point / Whit
• B33955222125: Insulated Electro-Needle for use in Regional Anesthesia, 22ga x 5.0" (127mm), Pencil Point / Whi
• B33955222070: Insulated Electro-Needle for use in Regional Anesthesia, 22ga x 3.0" (76mm), Pencil Point / Whit
• B339501120: Neuro-Trace II Lead Cable
• B339500020: Neuro-Trace II Nerve Locator