Duns Number:264502977
Device Description: "PEEK INSTRUMENT ADAPTOR Ø2.5MMinstrument Rosa One 3.1 (brain application)instrument adapt "PEEK INSTRUMENT ADAPTOR Ø2.5MMinstrument Rosa One 3.1 (brain application)instrument adaptor designed for guidance of biopsy needles, stimulation or recording electrodes"
Catalog Number
ROSAS00062
Brand Name
INST RND PEEK ADP Ø2.5MM
Version/Model Number
174092
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
2418e7ec-7338-4ff3-bdc0-0f115d70439c
Public Version Date
October 02, 2020
Public Version Number
3
DI Record Publish Date
July 26, 2019
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 251 |