Catalog Number

MK82AE111

Brand Name

EXMOOR

Version/Model Number

MK/82/A/E111

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

JYP

Product Code Name

Knife, Myringotomy

Public Device Record Key

c178b03e-aa6a-4f1a-8ef1-4b6d05ff8db8

Public Version Date

June 10, 2019

Public Version Number

3

DI Record Publish Date

October 10, 2018

Package DI Number

05060180253684

Quantity per Package

10

Contains DI Package

05060180252564

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

a box