Catalog Number

1092

Brand Name

Sterile Single-Use Surgical Probe Cover Kit

Version/Model Number

1092

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

Product Code

KKX

Product Code Name

Drape, Surgical

Public Device Record Key

49b3db07-9792-47e2-b83b-fc247a0ec29e

Public Version Date

July 29, 2021

Public Version Number

1

DI Record Publish Date

July 21, 2021

Package DI Number

10841912106964

Quantity per Package

24

Contains DI Package

00841912106967

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-