Catalog Number

1031

Brand Name

Sterile Probe Cover

Version/Model Number

1031

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

November 30, 2018

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

Product Code

KKX

Product Code Name

Drape, Surgical

Public Device Record Key

eaa87697-5f51-4171-a40c-2249c3db816f

Public Version Date

November 30, 2018

Public Version Number

3

DI Record Publish Date

July 13, 2018

Package DI Number

10841912105660

Quantity per Package

50

Contains DI Package

00841912105663

Package Discontinue Date

November 30, 2018

Package Status

Not in Commercial Distribution

Package Type

-