Catalog Number

1946

Brand Name

Surgical Probe Cover Kit

Version/Model Number

1946

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

290467bc-60fa-433f-a4c6-8b898a630bf4

Public Version Date

May 18, 2021

Public Version Number

2

DI Record Publish Date

June 01, 2020

Package DI Number

10841912106537

Quantity per Package

24

Contains DI Package

00841912106530

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-