Catalog Number

00505301200

Brand Name

MICRO 100

Version/Model Number

5053-012

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 27, 2022

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

-

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

-

Product Code

HTZ

Product Code Name

INSTRUMENT, CUTTING, ORTHOPEDIC

Public Device Record Key

9ca9b0d5-21e8-4a8f-8099-134f5bb8f71a

Public Version Date

October 28, 2022

Public Version Number

2

DI Record Publish Date

November 28, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-