Catalog Number

VB-2900-ARL

Brand Name

VASOBand

Version/Model Number

VB-2900-ARL

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

K190318,K190318

Product Code

DXC

Product Code Name

Clamp, Vascular

Public Device Record Key

cba13d3b-6d17-4e54-9cbd-0f44b10e61fa

Public Version Date

January 13, 2021

Public Version Number

1

DI Record Publish Date

January 05, 2021

Package DI Number

00860004749752

Quantity per Package

5

Contains DI Package

00866691000350

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shelf box