Catalog Number

ROSAS00081

Brand Name

SEEG DRILL ADAPTOR Ø2.15MM

Version/Model Number

174153

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

K182417,K200511

Product Code

HAW

Product Code Name

Neurological Stereotaxic Instrument

Public Device Record Key

e982214e-c4ad-4f7d-95f8-c2688af880c9

Public Version Date

July 12, 2022

Public Version Number

2

DI Record Publish Date

February 18, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-