Duns Number:131747628
Catalog Number
CS0208
Brand Name
Sonoma Orthopedic Products, Inc
Version/Model Number
3.2mm Long Cannulated Reamer
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
July 08, 2020
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
Yes
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
-
Product Code
HTO
Product Code Name
Reamer
Public Device Record Key
ccd03bb8-5e26-4cdd-94fe-8c38b369441b
Public Version Date
July 09, 2020
Public Version Number
6
DI Record Publish Date
November 30, 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 |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 6506 |
2 | A medical device with a moderate to high risk that requires special controls. | 3411 |
3 | A medical device with high risk that requires premarket approval | 1 |
U | Unclassified | 2 |