NeuroTrace 556-25-04

GUDID B33955625040

Insulated Electro-Needle for use in Regional Anesthesia, 25ga x 1.5" (38mm) , B Bevel

NEO MEDICAL INC.

Nerve-locating anaesthesia needle

• Primary Device ID: B33955625040
• NIH Device Record Key: cf2b8075-1034-4199-b8f0-3315ea0a9047
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NeuroTrace
• Version Model Number: 556-25-04
• Catalog Number: 556-25-04
• 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: 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: 888-450-3334
• Email: support@neomedicalinc.com
• Phone: 888-450-3334
• Email: support@neomedicalinc.com

Device Dimensions

• Length: 38 Millimeter
• Length: 1.5 Inch
• Needle Gauge: 25 Gauge
• Length: 38 Millimeter
• Length: 1.5 Inch
• Needle Gauge: 25 Gauge

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep Away From Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away From Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B33955625040 [Primary]
HIBCC	B33955625045 [Package]; Package: Case [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K032981

FDA Product Code

• BSP: Needle, Conduction, Anesthetic (W/Wo Introducer)

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-24

On-Brand Devices [NeuroTrace]

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• 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