Catalog Number

934401

Brand Name

General Purpose Probe Cover Kit

Version/Model Number

0128

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"

Yes

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

K970893,K970893

Product Code

KKX

Product Code Name

Drape, Surgical

Public Device Record Key

3af8d299-6c03-48ba-b23d-77d46f91ddf4

Public Version Date

May 17, 2021

Public Version Number

4

DI Record Publish Date

September 16, 2016

Package DI Number

10841912100023

Quantity per Package

20

Contains DI Package

00841912100026

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-