Catalog Number

-

Brand Name

MICROTEK

Version/Model Number

1

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

JOL

Product Code Name

CATHETER AND TIP, SUCTION

Public Device Record Key

171d2ea9-da30-406a-8f69-0d21f5f37d0a

Public Version Date

February 11, 2019

Public Version Number

3

DI Record Publish Date

November 04, 2016

Package DI Number

30748426072973

Quantity per Package

5

Contains DI Package

00748426072972

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-