Catalog Number

3249

Brand Name

Latex Endocavity Probe Cover Kit

Version/Model Number

3249

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)

Yes

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

K970891,K970891

Product Code

KKX

Product Code Name

Drape, Surgical

Public Device Record Key

9556d51a-f456-4b71-b027-69753ac76519

Public Version Date

March 22, 2022

Public Version Number

2

DI Record Publish Date

September 27, 2019

Package DI Number

10841912105950

Quantity per Package

40

Contains DI Package

00841912105953

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-