DEVICE: NeuroTrace (B33955718050)

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Device Identifier (DI) Information

NeuroTrace
557-18-05
557-18-05
NEO MEDICAL INC.
B33955718050
HIBCC
1
Insulated Electro-Needle for use in Regional Anesthesia, 18ga x 2.0" (51mm), Tuohy 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 kit, continuous-administration A collection of sterile devices designed to locate a peripheral nerve or nerve plexus with electrical neuromuscular stimulation, to target the percutaneous and continuous delivery of an anaesthetic for regional anaesthesia (RA). It typically includes a dedicated insulated needle or cannula with an uninsulated tip for nerve localization, an electrical cable for connection to a current generator, a catheter that may have a stimulatable stylet, a catheter inserter, and a syringe. The inserted catheter enables continuous nerve-block and localization perioperatively, and it is used to treat postoperative or chronic pain. This is a single-use device.
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FDA Product Code

[?]
Product Code Product Code Name
CAZ Anesthesia Conduction Kit
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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: 51 Millimeter
Length: 2.0 Inch
Needle Gauge: 18 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

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
B33955718055 10 B33955718050 In Commercial Distribution Case
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Secondary DI

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

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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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