Epimed - Wiley-Spinal™ Flexible Needle - EPIMED INTERNATIONAL, INC

Duns Number:799751953

Device Description: Wiley-Spinal™ Flexible Needle

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More Product Details

Catalog Number

199-2340

Brand Name

Epimed

Version/Model Number

199-2340

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

K043467,K043467

Product Code Details

Product Code

BSP

Product Code Name

NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)

Device Record Status

Public Device Record Key

84d1ed49-071e-4e1b-b800-3959bd3c77a1

Public Version Date

July 22, 2019

Public Version Number

4

DI Record Publish Date

October 24, 2017

Additional Identifiers

Package DI Number

10818788021691

Quantity per Package

10

Contains DI Package

00818788021694

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