Duns Number:002397347
Device Description: INTROCAN SAFETY FEP 20G, 1.1X25MM-US
Catalog Number
4252543-020
Brand Name
INTROCAN SAFETY®
Version/Model Number
4252543-020
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
DYB
Product Code Name
INTRODUCER, CATHETER
Public Device Record Key
82857ad7-38de-45a8-b8d7-97bb7338349e
Public Version Date
June 10, 2022
Public Version Number
12
DI Record Publish Date
September 23, 2016
Package DI Number
04046964398957
Quantity per Package
4
Contains DI Package
04046964398940
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 |