Catalog Number

EPL1A or EPL1B

Brand Name

EXMOOR

Version/Model Number

EPL1

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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,K093863

Product Code

FMF

Product Code Name

Syringe, Piston

Public Device Record Key

6e3ccb59-2997-44e9-9f33-c8ed24a543dc

Public Version Date

November 26, 2019

Public Version Number

1

DI Record Publish Date

November 18, 2019

Package DI Number

05060180256456

Quantity per Package

10

Contains DI Package

05060180254643

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

a box