Duns Number:117523635
Device Description: Clearsight Bolus, 1.0cm water equivalent thickness, 1.15cm physical thickness, Clear, 40cm Clearsight Bolus, 1.0cm water equivalent thickness, 1.15cm physical thickness, Clear, 40cm x 40cm
Catalog Number
-
Brand Name
Clearsight Bolus
Version/Model Number
B-11-20-01
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
-
Product Code
IXG
Product Code Name
Phantom, Anthropomorphic, Radiographic
Public Device Record Key
1b99f360-4383-4e9e-bd85-423f8223d8fa
Public Version Date
May 23, 2022
Public Version Number
1
DI Record Publish Date
May 13, 2022
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 | 5 |