Novo Surgical - fixation base, support for brain spatulas w/ - NOVO SURGICAL, INC.

Duns Number:033029433

Device Description: fixation base, support for brain spatulas w/ round handle (also for hand instruments w/ ro fixation base, support for brain spatulas w/ round handle (also for hand instruments w/ round handle)

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

-

Brand Name

Novo Surgical

Version/Model Number

N6860-43

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

-

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

GZT

Product Code Name

Retractor, Self-Retaining, For Neurosurgery

Device Record Status

Public Device Record Key

3cb77247-84f5-48ed-a674-8f4870047ec3

Public Version Date

May 14, 2019

Public Version Number

1

DI Record Publish Date

May 06, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"NOVO SURGICAL, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 3
2 A medical device with a moderate to high risk that requires special controls. 2724