Duns Number:002397347
Device Description: Introcan Safety® 3 Closed IV Catheter 16 Ga. x 1.25 in., PUR, Winged
Catalog Number
4251136-02
Brand Name
INTROCAN SAFETY® 3
Version/Model Number
4251136-02
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
FOZ
Product Code Name
Catheter,intravascular,therapeutic,short-term less than 30 days
Public Device Record Key
16e2a24b-be65-4f35-b695-c04d0ed9f439
Public Version Date
June 10, 2022
Public Version Number
10
DI Record Publish Date
January 08, 2018
Package DI Number
04046964369926
Quantity per Package
4
Contains DI Package
04046964369919
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 16 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 277 |
| U | Unclassified | 2 |