Duns Number:755092467
Device Description: Accessories Kit (consists of 1 delivery set, 1 v-vial and 1 v-vial holder)
Catalog Number
-
Brand Name
SIR-Spheres Accessories Pack
Version/Model Number
SIR-K002
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
64326aba-fe54-45ed-8dc1-9286d6cad377
Public Version Date
January 19, 2022
Public Version Number
2
DI Record Publish Date
July 14, 2021
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 | 9 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |
| 3 | A medical device with high risk that requires premarket approval | 1 |