DEVICE: EchoTuohy Epidural Needle (04526737171067)

Device Identifier (DI) Information

EchoTuohy Epidural Needle
E5-2150-17
In Commercial Distribution

HAKKO CO.,LTD.
04526737171067
GS1

1
693273427 *Terms of Use
17G x 5"(127mm) Plastic hub, with wings Calibrations & Echogenic Tip.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. The copyright and database rights in the original GMDN materials are owned by The GMDN Agency Ltd 2005-2023. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
58293 Epidural needle, non-threaded
A sterile, sharp bevel-edged, hollow tubular metal instrument designed to access the epidural space. It may be used to deliver anaesthetic or analgesic agents or to introduce a dedicated catheter for continuous anaesthesia administration. If used with a stylet, it is often referred to as a cannula. This is a single-use device.
Active false
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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 [?]
K961152 000
No CLOSE

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: 17 Gauge
Length: 127 Millimeter
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Device Record Status

b26093d1-0f40-4cf7-8061-af8eec099773
June 03, 2022
4
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
14526737171064 10 04526737171067 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

[?]
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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