Catalog Number

-

Brand Name

Probe Storage Covers

Version/Model Number

1140

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,K970889

Product Code

KKX

Product Code Name

Drape, Surgical

Public Device Record Key

c1984c40-2ab7-4e9a-a0fa-995e26aafe82

Public Version Date

September 28, 2021

Public Version Number

1

DI Record Publish Date

September 20, 2021

Package DI Number

20841912104714

Quantity per Package

4

Contains DI Package

10841912104717

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-