Duns Number:264502977
Device Description: Cannula Ø6/Ø4mm L 200mm instrument Rosa one 3.1 (spine application)Cannula OD 6.0mm ID 4.0 Cannula Ø6/Ø4mm L 200mm instrument Rosa one 3.1 (spine application)Cannula OD 6.0mm ID 4.0mm"
Catalog Number
ROSAS00154
Brand Name
CANNULA Ø 6 - 4 MM L 200 MM
Version/Model Number
224170-01
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
567337a5-a1fb-4430-9315-a8595f027fa0
Public Version Date
July 13, 2022
Public Version Number
3
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 |