Catalog Number

MK7NSJ1E116

Brand Name

EXMOOR

Version/Model Number

MK7NSJ1E116

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

f45280a8-b0b2-490e-b3c2-ad22a751c571

Public Version Date

June 07, 2019

Public Version Number

1

DI Record Publish Date

May 30, 2019

Package DI Number

05060180255022

Quantity per Package

10

Contains DI Package

05060180259068

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

a box