Catalog Number

EPL1A

Brand Name

EXMOOR

Version/Model Number

EPL/1a

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

November 01, 2019

Issuing Agency

In GS1

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K093863,K093863

Product Code

FMF

Product Code Name

Syringe, Piston

Public Device Record Key

a8b37ecb-d600-44fd-a9c3-b4533ca9caed

Public Version Date

November 19, 2019

Public Version Number

3

DI Record Publish Date

September 21, 2018

Package DI Number

05060180252113

Quantity per Package

100

Contains DI Package

05060180258788

Package Discontinue Date

November 01, 2019

Package Status

Not in Commercial Distribution

Package Type

-