Catalog Number

613349

Brand Name

Micro-Access Elite®

Version/Model Number

613349

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 11, 2021

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"

Yes

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

K043525

Product Code

DYB

Product Code Name

INTRODUCER, CATHETER

Public Device Record Key

465bcfd1-9290-49b3-9db7-75cf4165d097

Public Version Date

March 15, 2021

Public Version Number

5

DI Record Publish Date

August 09, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-