Catalog Number

UK12-197SF

Brand Name

EXMOOR

Version/Model Number

UK12-197SF

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

JZF

Product Code Name

Tube, Ear Suction

Public Device Record Key

77f54334-75bb-4d61-9073-557600c159f4

Public Version Date

April 20, 2020

Public Version Number

4

DI Record Publish Date

September 13, 2018

Package DI Number

05060180250133

Quantity per Package

50

Contains DI Package

05060180258450

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

a box