Catalog Number

ROSAS00068

Brand Name

PEEK INSTRUMENT ADAPTOR Ø2MM

Version/Model Number

174092-01

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

16eb3945-7f0c-47a4-9263-5dc6c6c21976

Public Version Date

October 02, 2020

Public Version Number

3

DI Record Publish Date

June 01, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-