Duns Number:318130267
Device Description: Click-Tip Injection Needle, 22 G, Needle Length 6 mm, Catheter Diameter 1.9 mm, Sheath Len Click-Tip Injection Needle, 22 G, Needle Length 6 mm, Catheter Diameter 1.9 mm, Sheath Length 180 cm
Catalog Number
03-19-180
Brand Name
Click-Tip
Version/Model Number
03-19-180
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"
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
FBK
Product Code Name
Endoscopic Injection Needle, Gastroenterology-Urology
Public Device Record Key
ec65795c-2228-4ac4-8fa1-4db918378d93
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 21, 2016
Package DI Number
4052838015554
Quantity per Package
10
Contains DI Package
04052838015547
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. | 51 |