Catalog Number

1031

Brand Name

Sterile Probe Cover Kit with PullUp/pull off extension

Version/Model Number

1031

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

4846e1e6-93b7-45aa-b507-87aff859c004

Public Version Date

December 17, 2018

Public Version Number

1

DI Record Publish Date

November 16, 2018

Package DI Number

10841912105882

Quantity per Package

50

Contains DI Package

00841912105885

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-