Epimed - 25g TW x 4.5" Quincke Spinal Needle w/ Introducer - EPIMED INTERNATIONAL, INC

Duns Number:799751953

Device Description: 25g TW x 4.5" Quincke Spinal Needle w/ Introducer

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More Product Details

Catalog Number

130-2545

Brand Name

Epimed

Version/Model Number

130-2545

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Unsafe

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

K022029,K022029

Product Code Details

Product Code

BSP

Product Code Name

NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)

Device Record Status

Public Device Record Key

8fe0d8c2-1e80-4794-a725-a6efaaea4441

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

October 20, 2017

Additional Identifiers

Package DI Number

10818788020885

Quantity per Package

10

Contains DI Package

00818788020888

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case

"EPIMED INTERNATIONAL, INC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 293