Duns Number:542984702
Device Description: the Catheter OD is 2.4mm, working length is 2300mm, model of needle is 21, needle extensio the Catheter OD is 2.4mm, working length is 2300mm, model of needle is 21, needle extension length is 4 mm, the headend type is metal cap.
Catalog Number
-
Brand Name
NA
Version/Model Number
AG-5313-2423-2104M
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
K190032,K190032,K190032
Product Code
FBK
Product Code Name
Endoscopic Injection Needle, Gastroenterology-Urology
Public Device Record Key
5ca926b0-a113-402c-9f45-055c530b9407
Public Version Date
December 14, 2021
Public Version Number
1
DI Record Publish Date
December 06, 2021
Package DI Number
16959664941529
Quantity per Package
10
Contains DI Package
06959664941522
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 2 |