Duns Number:066839630
Device Description: APPLICATOR TIP DUAL LUMEN (Cannula) Endoscopic Semi-Flexible 5 MM X 32 cm (12.5 IN)
Catalog Number
-
Brand Name
FIBRIJET
Version/Model Number
SA-3650
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 31, 2022
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"
Yes
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
FMF
Product Code Name
Syringe, Piston
Public Device Record Key
cd0e30fd-232a-4a31-93ed-3acfd347fa33
Public Version Date
November 01, 2022
Public Version Number
5
DI Record Publish Date
September 25, 2016
Package DI Number
10815634020150
Quantity per Package
10
Contains DI Package
00815634020153
Package Discontinue Date
March 01, 2021
Package Status
Not in Commercial Distribution
Package Type
SHELF BOX
| 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 |