Catalog Number

S1011/390/SR

Brand Name

EXMOOR

Version/Model Number

S1011/390/SR

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 31, 2019

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

4ff7e1cd-799e-4c59-b440-4c2fe971eccc

Public Version Date

April 20, 2020

Public Version Number

4

DI Record Publish Date

September 14, 2018

Package DI Number

05060180254773

Quantity per Package

25

Contains DI Package

05060180258900

Package Discontinue Date

October 31, 2019

Package Status

Not in Commercial Distribution

Package Type

a box