Duns Number:688256864
Device Description: 23G-4mm/ 0.1T/ 2,300mm/ Non-head
Catalog Number
-
Brand Name
Clear-Jet Injection Catheter
Version/Model Number
FM-EI0002(I2)(2300)(0.1T)
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
K181690,K181690
Product Code
FBK
Product Code Name
Endoscopic Injection Needle, Gastroenterology-Urology
Public Device Record Key
83f74257-dc94-44d9-968b-2093b61eb7ff
Public Version Date
April 22, 2019
Public Version Number
1
DI Record Publish Date
April 12, 2019
Package DI Number
18809327350664
Quantity per Package
10
Contains DI Package
08809327350667
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 6 |
2 | A medical device with a moderate to high risk that requires special controls. | 53 |