Catalog Number

ACC-5DRS

Brand Name

Vcare Alpha

Version/Model Number

Drape Accessory Pack

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

-

Product Code

MKY

Product Code Name

System, Skin Closure

Public Device Record Key

ed3582db-c078-4ec6-9f0a-7548aacefeae

Public Version Date

November 23, 2021

Public Version Number

3

DI Record Publish Date

August 13, 2017

Package DI Number

17290111494205

Quantity per Package

40

Contains DI Package

07290111494208

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Distribution Carton