Catalog Number

-

Brand Name

VascuLoop

Version/Model Number

VascuLoop

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

K122735,K122735

Product Code

GAT

Product Code Name

SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE

Public Device Record Key

be2125e4-ce80-4b51-9717-4e2354434fbf

Public Version Date

February 05, 2021

Public Version Number

6

DI Record Publish Date

March 15, 2016

Package DI Number

10803622130844

Quantity per Package

12

Contains DI Package

00803622130847

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE