Catalog Number

MK92E

Brand Name

EXMOOR

Version/Model Number

MK/92/E

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

8cb119e9-7dc7-43fe-bcc0-8058feefa03b

Public Version Date

June 05, 2019

Public Version Number

3

DI Record Publish Date

September 19, 2018

Package DI Number

05060180254483

Quantity per Package

10

Contains DI Package

05060180258771

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

a box