Catalog Number

ROSAS00322

Brand Name

INOMED MICRODRIVE HOLDER (ZD/RM 590071)

Version/Model Number

ROSA3-197A

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

-

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

K151359,K172444,K182417,K200511

Product Code

HAW

Product Code Name

Neurological Stereotaxic Instrument

Public Device Record Key

5d6d1cad-d731-4e77-848a-0cc18c423091

Public Version Date

October 02, 2020

Public Version Number

6

DI Record Publish Date

October 09, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-