Duns Number:042823948
Device Description: Flexor, Check-Flo, Introducer Ansel 1 Modification - with High-Flex Dilator and Hydrophili Flexor, Check-Flo, Introducer Ansel 1 Modification - with High-Flex Dilator and Hydrophilic Coating
Catalog Number
KCFW-7.0-35-70-RB-HFANL1-HC
Brand Name
Flexor
Version/Model Number
G56227
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
DYB
Product Code Name
INTRODUCER, CATHETER
Public Device Record Key
abb0c2c3-8f93-46fc-a514-fc79e99714af
Public Version Date
June 07, 2019
Public Version Number
3
DI Record Publish Date
September 24, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 669 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8328 |
| 3 | A medical device with high risk that requires premarket approval | 370 |
| U | Unclassified | 242 |