Duns Number:146920025
Device Description: The High Dose Rate Frame, when used in conjunction with a High Dose Rate Sandwich, is used The High Dose Rate Frame, when used in conjunction with a High Dose Rate Sandwich, is used for assisting the physician in placement of the brachytherapy needles for prostate brachytherapy procedures.
Catalog Number
-
Brand Name
High Dose Rate Frame, Best Precision Stepper (Siemens Grid)
Version/Model Number
6012
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K973786
Product Code
IWJ
Product Code Name
System, Applicator, Radionuclide, Manual
Public Device Record Key
f3c9f4ec-60ae-4722-a2cb-bec96c0a6e66
Public Version Date
June 17, 2022
Public Version Number
6
DI Record Publish Date
October 31, 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 | 35 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 15 |