Duns Number:933506164
Catalog Number
-
Brand Name
ShadowForm Marker
Version/Model Number
S-SF5001
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K964972
Product Code
KPQ
Product Code Name
System, Simulation, Radiation Therapy
Public Device Record Key
d54f4add-a984-44ae-8e92-3f2cf62b944e
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
February 07, 2017
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 | 98 |
2 | A medical device with a moderate to high risk that requires special controls. | 518 |