Catalog Number

ROSAS00084

Brand Name

SEEG SST DRILL ADAPTOR Ø3.2MM

Version/Model Number

174045-01

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

82f3b02a-a62c-418b-a21d-82d52978b254

Public Version Date

July 12, 2022

Public Version Number

4

DI Record Publish Date

June 01, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-