Duns Number:264502977
Device Description: Trnsnsl Endscp Rnd Ø5.1mm Holderinstrument Rosa 3.0instrument Rosa 3.1instrument holder fo Trnsnsl Endscp Rnd Ø5.1mm Holderinstrument Rosa 3.0instrument Rosa 3.1instrument holder for guidance of a Storz sheath 28164 ASA-CBF during endonasal procedures, positioned by the robot arm in accordance with pre- operative plan
Catalog Number
ROSAS00320
Brand Name
TRANSNASAL ENDOSCOPY STORZ 28164 ASA-CBF HOLDER
Version/Model Number
ROSA3-279A
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
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
K151359,K172444,K182417,K200511
Product Code
HAW
Product Code Name
Neurological Stereotaxic Instrument
Public Device Record Key
df23496a-0fec-41e0-9aa1-d7641707d9b5
Public Version Date
July 12, 2022
Public Version Number
7
DI Record Publish Date
October 09, 2016
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 |