Duns Number:016898496
Device Description: BrachyStar Brachytherapy Applicator Seed Implant Needle with Lubricious Coating and cm Mar BrachyStar Brachytherapy Applicator Seed Implant Needle with Lubricious Coating and cm Markings, 18g x 20cm Length
Catalog Number
918205
Brand Name
Seed Implant Needle
Version/Model Number
918205
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
IWJ
Product Code Name
System, applicator, radionuclide, manual
Public Device Record Key
347a9d57-1991-408d-8fc0-8362d02fa239
Public Version Date
September 30, 2020
Public Version Number
1
DI Record Publish Date
September 22, 2020
Package DI Number
20801741075968
Quantity per Package
10
Contains DI Package
10801741075961
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CA
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 472 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1994 |
| U | Unclassified | 10 |