Catalog Number

-

Brand Name

FLUORO 3D KIT (FOR 3D C-ARMS)

Version/Model Number

55715-10

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

K070106,K183605

Product Code

HAW

Product Code Name

Neurological Stereotaxic Instrument

Public Device Record Key

63980a58-b39c-4f24-b0f3-8c480c1669c5

Public Version Date

December 11, 2019

Public Version Number

2

DI Record Publish Date

August 24, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-