Catalog Number

E202

Brand Name

EXMOOR

Version/Model Number

E.202

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

K911503,K911503

Product Code

KHJ

Product Code Name

Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)

Public Device Record Key

a5daa757-748d-46e2-925f-970b1f08de3f

Public Version Date

October 15, 2019

Public Version Number

2

DI Record Publish Date

September 21, 2018

Package DI Number

05060180251987

Quantity per Package

25

Contains DI Package

05060180256135

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

a box