Disposable Reflective Marker Spheres (DRMS) - Disposable Reflective Marker Spheres (DRMS) - Northern Digital Inc

Duns Number:241987692

Device Description: Disposable Reflective Marker Spheres (DRMS) attached to reference frames and surgical inst Disposable Reflective Marker Spheres (DRMS) attached to reference frames and surgical instruments for use during surgical navigation in image guided surgery. One retail carton is made up of 3 spheres per tray, 90 trays, 270 spheres total.

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More Product Details

Catalog Number

41774

Brand Name

Disposable Reflective Marker Spheres (DRMS)

Version/Model Number

41774

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code Details

Product Code

HAW

Product Code Name

Neurological Stereotaxic Instrument

Device Record Status

Public Device Record Key

2fbf2eaf-d638-48c7-8169-57af673e99e4

Public Version Date

May 30, 2018

Public Version Number

3

DI Record Publish Date

September 24, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"NORTHERN DIGITAL INC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 14