Duns Number:264502977
Device Description: Patient Reference Adaptorinstrument Rosa one 3.1 (spine application)Adaptor to mount patie Patient Reference Adaptorinstrument Rosa one 3.1 (spine application)Adaptor to mount patient reference on percutaneous pin or clamp"
Catalog Number
ROSAS00152
Brand Name
PATIENT REFERENCE STARBURST ADAPTOR
Version/Model Number
174024-01
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
K182848,K192173
Product Code
OLO
Product Code Name
Orthopedic Stereotaxic Instrument
Public Device Record Key
3cbe5284-d035-452a-b76b-05dbc9b456ae
Public Version Date
July 12, 2022
Public Version Number
3
DI Record Publish Date
June 02, 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 |