Duns Number:339852325
Device Description: The absorber shields are discs used to radioprotect the patient’s organs. They shall be in The absorber shields are discs used to radioprotect the patient’s organs. They shall be inserted below the tissue treated during the surgery. They can be inserted within the surgical incision.
Catalog Number
N394080-02-05
Brand Name
ABSORBER SHIELD
Version/Model Number
Diameter 80 mm
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
-
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
K112286
Product Code
IYE
Product Code Name
Accelerator, Linear, Medical
Public Device Record Key
cafb26a8-8f06-42f7-bfce-3d612b8e3666
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 12, 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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 9 |