Catalog Number

VPC1646NS

Brand Name

Non-Sterile Endocavity Probe Cover with Rubber Bands

Version/Model Number

1052

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

K970889,K970889

Product Code

KKX

Product Code Name

Drape, Surgical

Public Device Record Key

7f9dd5a6-bd56-49a7-847b-19bc630c7ca5

Public Version Date

October 15, 2018

Public Version Number

1

DI Record Publish Date

September 14, 2018

Package DI Number

10841912105820

Quantity per Package

50

Contains DI Package

00841912105823

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-