DEVICE: NeuroTrace (B33955325040)

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Device Identifier (DI) Information

NeuroTrace
553-25-04
553-25-04
NEO MEDICAL INC.
B33955325040
HIBCC
1
Insulated Electro-Needle for use in Regional Anesthesia, 25ga x 1.5" (38mm), B Bevel
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Device Characteristics

MR Unsafe
No
Yes
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Nerve-locating anaesthesia needle A sterile device intended to functions as: 1) an electrode during nerve/nerve plexus location; and 2) as a conduit for administration of a local anaesthetic during peripheral nerve-blocking. It is a sharp, hollow, tubular, electrically-insulated metal needle with an uninsulated bevelled tip, intended to be used with an electrical pulse generator and an appropriate anaesthetic-filled syringe. This is a single-use device.
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FDA Product Code

[?]
Product Code Product Code Name
BSP Needle, Conduction, Anesthetic (W/Wo Introducer)
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Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Special Storage Condition, Specify: Keep Away From Sunlight
Special Storage Condition, Specify: Keep Dry
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Clinically Relevant Size

[?]
Size Type Text
Length: 38 Millimeter
Length: 1.5 Inch
Needle Gauge: 25 Gauge
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Device Status

In Commercial Distribution
September 24, 2016

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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
B33955325045 25 B33955325040 In Commercial Distribution Case
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
Yes
No CLOSE

Customer Contact

[?]
888-450-3334
support@neomedicalinc.com
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