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

KKX

Product Code Name

Drape, Surgical

Public Device Record Key

af90248d-9b57-4a00-af44-65e8a3dd7156

Public Version Date

December 14, 2020

Public Version Number

1

DI Record Publish Date

December 04, 2020

Package DI Number

80841912104266

Quantity per Package

4

Contains DI Package

70841912104269

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-