Catalog Number

3241

Brand Name

Non-Sterile Latex Endocavity Probe Cover

Version/Model Number

3241

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

56caf23d-ac12-4412-8bfd-9631fc1420f7

Public Version Date

July 06, 2018

Public Version Number

4

DI Record Publish Date

October 13, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-