Catalog Number

-

Brand Name

Non-Sterile Probe Storage Covers

Version/Model Number

1160

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

K970889,K970889,K970889

Product Code

MMP

Product Code Name

Cover, Barrier, Protective

Public Device Record Key

12f08e22-414d-4437-94a4-85fc978d2387

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

October 10, 2016

Package DI Number

40841912104268

Quantity per Package

4

Contains DI Package

30841912104261

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-