Duns Number:803580559
Device Description: MOUSE 9732721 STERILE O-ARM 10PK
Catalog Number
-
Brand Name
O-ARM®
Version/Model Number
9732721
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
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
K060344,K060344
Product Code
OXO
Product Code Name
Image-intensified fluoroscopic x-ray system, mobile
Public Device Record Key
d3788508-1df0-42cf-8ddc-f342b69d9c5b
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 18, 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 | 23 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1961 |
| 3 | A medical device with high risk that requires premarket approval | 1 |