Tuohy Epidural Needle - 18G x 3 1/2"(89mm)Plastic hubWith wings, - HAKKO CO.,LTD.

Duns Number:693273427

Device Description: 18G x 3 1/2"(89mm)Plastic hubWith wings, calibrations

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More Product Details

Catalog Number

-

Brand Name

Tuohy Epidural Needle

Version/Model Number

3-2150-18

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K961152,K961152

Product Code Details

Product Code

BSP

Product Code Name

Needle, Conduction, Anesthetic (W/Wo Introducer)

Device Record Status

Public Device Record Key

214b4833-78c8-4ee6-87b4-3bdca9a8f09c

Public Version Date

June 03, 2022

Public Version Number

4

DI Record Publish Date

September 23, 2016

Additional Identifiers

Package DI Number

14526737170852

Quantity per Package

10

Contains DI Package

04526737170855

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"HAKKO CO.,LTD." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 94