Catalog Number

134-1420

Brand Name

Epimed

Version/Model Number

134-1420

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

K051860,K051860

Product Code

MIA

Product Code Name

NEEDLE, SPINAL, SHORT TERM

Public Device Record Key

9ec93d78-9df4-494f-bd17-b7767f6805eb

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

October 30, 2017

Package DI Number

10818788020892

Quantity per Package

10

Contains DI Package

00818788020895

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case