Duns Number:081299204
Device Description: Preloaded flexible braided strands with Cs-131 Brachytherapy seeds inside a purified colla Preloaded flexible braided strands with Cs-131 Brachytherapy seeds inside a purified collagen carrier
Catalog Number
-
Brand Name
GammaTile™
Version/Model Number
GT-001
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Conditional
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
KXK
Product Code Name
Source, Brachytherapy, Radionuclide
Public Device Record Key
81dc6a43-b90f-4e91-af15-d412c3d00ba1
Public Version Date
February 06, 2020
Public Version Number
3
DI Record Publish Date
September 01, 2018
Package DI Number
60860000064509
Quantity per Package
6
Contains DI Package
00860000064507
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Outer Pouch
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1 |