Catalog Number

2648

Brand Name

Sterile Single-Use Probe Cover Kit

Version/Model Number

2648

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

7d450cbe-88a7-46d0-9413-f49946370e4e

Public Version Date

March 21, 2022

Public Version Number

1

DI Record Publish Date

March 11, 2022

Package DI Number

10841912107084

Quantity per Package

24

Contains DI Package

00841912107087

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-