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

NAY

Product Code Name

System,surgical,computer controlled instrument

Public Device Record Key

50b87429-862f-40e9-a258-f4f4e3794851

Public Version Date

June 08, 2021

Public Version Number

5

DI Record Publish Date

November 16, 2016

Package DI Number

50748426077378

Quantity per Package

50

Contains DI Package

00748426077373

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-