Duns Number:066839630
Device Description: Applicator Tip, Dual Cannula, 20 ga. X 10 1/4” (26cm)
Catalog Number
-
Brand Name
FibriJet
Version/Model Number
SA-3620
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
KYZ
Product Code Name
Syringe, Irrigating (Non Dental)
Public Device Record Key
0dce2167-6509-4b8f-8ec0-cb97c1f1dc35
Public Version Date
October 28, 2022
Public Version Number
2
DI Record Publish Date
June 06, 2022
Package DI Number
10815634021584
Quantity per Package
10
Contains DI Package
00815634021587
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Inner Pack
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 35 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 34 |