DEVICE: EchoStim (04526737170626)

Device Identifier (DI) Information

EchoStim
ES-2180
In Commercial Distribution

HAKKO CO.,LTD.
04526737170626
GS1

1
693273427 *Terms of Use
21G x 3 1/8"(80mm) Facet tip
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
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, single-administration A collection of sterile devices designed to locate a peripheral nerve or nerve plexus with electrical neuromuscular stimulation, to target the percutaneous delivery of a single injection of an anaesthetic for regional anaesthesia (RA). It typically includes an insulated needle with an uninsulated bevelled tip that functions as an electrode during nerve location and as a conduit during anaesthesia administration, an electrical cable that connects to a current generator, and an extension tube that connects to 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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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K063380 000
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Sterilization

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

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
Needle Gauge: 21 Gauge
Length: 80 Millimeter
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Device Record Status

fa617564-6590-46b6-a0c6-1b1835b65574
July 06, 2018
3
September 23, 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
14526737170623 25 04526737170626 In Commercial Distribution
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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
No
No CLOSE

Customer Contact

[?]
513-271-2117
SAst@havels.com
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