Catalog Number

AS3A

Brand Name

EXMOOR

Version/Model Number

AS3A

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

-

Product Code

EPY

Product Code Name

Speculum, Ent

Public Device Record Key

f47729f4-7ac6-49f2-90c2-8523ea034df0

Public Version Date

June 07, 2019

Public Version Number

2

DI Record Publish Date

September 17, 2018

Package DI Number

05060180251819

Quantity per Package

30

Contains DI Package

05060180255695

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

a box