Catalog Number

-

Brand Name

Cirq Robotic Biopsy Drill Bit 3.4 Cranial

Version/Model Number

56405-01A

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 31, 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

K210989

Product Code

HAW

Product Code Name

Neurological Stereotaxic Instrument

Public Device Record Key

19ea2fcc-54c8-44a4-882a-6b830a6fc0dd

Public Version Date

September 01, 2022

Public Version Number

2

DI Record Publish Date

November 24, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-