Catalog Number

-

Brand Name

VasoGrad

Version/Model Number

VG501L

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

K061967,K102732,K061967,K102732,K061967,K102732,K061967,K102732,K061967,K102732

Product Code

JOW

Product Code Name

Sleeve, Limb, Compressible

Public Device Record Key

841c67a3-859a-46f5-ad78-4311466b1440

Public Version Date

October 23, 2018

Public Version Number

4

DI Record Publish Date

September 22, 2016

Package DI Number

40815245011074

Quantity per Package

2880

Contains DI Package

00815245011038

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-