Catalog Number

1911-512

Brand Name

Epimed

Version/Model Number

1911-512

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

K020926,K020926

Product Code

FPA

Product Code Name

Set, administration, intravascular

Public Device Record Key

248917e9-c092-484d-8c7a-aa8fc555aff4

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

October 24, 2017

Package DI Number

10818788021592

Quantity per Package

10

Contains DI Package

00818788021595

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case