Catalog Number

-

Brand Name

VasoGrad

Version/Model Number

VG501B

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"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K102732,K991038,K102732,K991038,K102732,K991038,K102732,K991038,K102732,K991038

Product Code

JOW

Product Code Name

Sleeve, Limb, Compressible

Public Device Record Key

1e8baf3e-7176-438a-8b92-9b67e74e1101

Public Version Date

October 23, 2018

Public Version Number

4

DI Record Publish Date

September 23, 2016

Package DI Number

40815245012064

Quantity per Package

1440

Contains DI Package

00815245012028

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-