Duns Number:264502977
Device Description: 3D X-RAY PATTERN PHANTOMinstrument Rosa one (spine application)Mock-up of the 3D X-ray pat 3D X-RAY PATTERN PHANTOMinstrument Rosa one (spine application)Mock-up of the 3D X-ray pattern to adjust intraoperative imaging system
Catalog Number
ROSAS00156
Brand Name
3D X-RAY PATTERN PHANTOM
Version/Model Number
ROSA3-129B
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
808ee85c-c8ae-40ba-8a46-c4975edcd229
Public Version Date
September 01, 2021
Public Version Number
4
DI Record Publish Date
November 18, 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 |