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

K001082,K001082

Product Code

FYD

Product Code Name

APPARATUS, EXHAUST, SURGICAL

Public Device Record Key

2467f0e8-f7c5-479b-ba5a-f3559df05547

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

November 04, 2016

Package DI Number

50748426092081

Quantity per Package

10

Contains DI Package

00748426092086

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-