Duns Number:318130267
Device Description: Injection Needle / Sclerotherapy Needle , 25 Gauge, needle length 4 mm, tube diameter 1.9 Injection Needle / Sclerotherapy Needle , 25 Gauge, needle length 4 mm, tube diameter 1.9 mm, working length 230 cm
Catalog Number
GSN-05-19-230
Brand Name
Injectra, Sclero Tip
Version/Model Number
GSN-05-19-230
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
FBK
Product Code Name
Endoscopic Injection Needle, Gastroenterology-Urology
Public Device Record Key
8e8df171-0386-4d7f-975d-890130f01cab
Public Version Date
May 23, 2019
Public Version Number
1
DI Record Publish Date
May 15, 2019
Package DI Number
04052838009683
Quantity per Package
10
Contains DI Package
04052838009676
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 |