Catalog Number

1160

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

2a34ac65-51d4-44dd-bd75-a0e30b09df33

Public Version Date

June 18, 2019

Public Version Number

1

DI Record Publish Date

June 10, 2019

Package DI Number

60841912104262

Quantity per Package

4

Contains DI Package

50841912104265

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-