Catalog Number

-

Brand Name

Probe Cover

Version/Model Number

2322

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

K970893,K970893

Product Code

KKX

Product Code Name

Drape, Surgical

Public Device Record Key

9a620cd1-817d-4a68-bce1-723c92552329

Public Version Date

August 26, 2019

Public Version Number

1

DI Record Publish Date

August 16, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-