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, 17g x 20cm Length
Catalog Number
917201
Brand Name
Seed Implant Needle
Version/Model Number
917201
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
7cba5a31-ffab-4284-8d57-61f26644cbb7
Public Version Date
September 29, 2020
Public Version Number
1
DI Record Publish Date
September 21, 2020
Package DI Number
10801741075930
Quantity per Package
10
Contains DI Package
00801741075933
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 |