Catalog Number

VPC5536

Brand Name

General Purpose Probe Cover

Version/Model Number

2323

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

52e5c634-6061-4c91-83cf-4516da92994f

Public Version Date

December 27, 2021

Public Version Number

1

DI Record Publish Date

December 17, 2021

Package DI Number

10841912107053

Quantity per Package

24

Contains DI Package

00841912107056

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-