Duns Number:488052341
Device Description: Sepax Kit Accessory
Catalog Number
10043
Brand Name
Double Spike Accessory
Version/Model Number
FA-200.1
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
JQC
Product Code Name
Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use
Public Device Record Key
2b3ed28b-f2c6-40cc-9aeb-0b11712b1d2a
Public Version Date
March 09, 2022
Public Version Number
3
DI Record Publish Date
January 13, 2017
Package DI Number
07640125650358
Quantity per Package
24
Contains DI Package
07640125650341
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 | 7 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 24 |