Duns Number:264502977
Device Description: Trnsnsl Endscp Rnd Ø5.1mm HolderInstrument ROSA One 3.1 (brain application)Instrument hold Trnsnsl Endscp Rnd Ø5.1mm HolderInstrument ROSA One 3.1 (brain application)Instrument holder for guidance an endoscope during endonasal procedures. Positioned by the robot arm in accordance with a pre-operative plan.
Catalog Number
ROSAS00320
Brand Name
TRANSNASAL ENDOSCOPY INTRUMENT HOLDER Ø 5,1 mm
Version/Model Number
174040-00
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
K200511
Product Code
HAW
Product Code Name
Neurological Stereotaxic Instrument
Public Device Record Key
7d779761-d67a-434b-a1e0-9722a3e5aa68
Public Version Date
July 12, 2022
Public Version Number
2
DI Record Publish Date
October 20, 2020
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 |