Catalog Number

70106.3540

Brand Name

AVALON ELITE

Version/Model Number

VAK

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

K081940,K081940

Product Code

DRE

Product Code Name

Dilator, Vessel, For Percutaneous Catheterization

Public Device Record Key

1347550f-2e07-4b6c-8a27-68b0bd976fdc

Public Version Date

June 07, 2019

Public Version Number

5

DI Record Publish Date

January 13, 2016

Package DI Number

04037691995434

Quantity per Package

5

Contains DI Package

04037691831039

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-