Duns Number:134139174
Device Description: EDWARDS DILATOR KIT
Catalog Number
9100DKSA
Brand Name
EDWARDS DILATOR KIT
Version/Model Number
9100DKSA
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
DRE
Product Code Name
DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION
Public Device Record Key
eae3668e-b0c5-42f1-98e3-43b5bb1c3a8d
Public Version Date
July 04, 2022
Public Version Number
7
DI Record Publish Date
December 01, 2015
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 | 5 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 643 |
| 3 | A medical device with high risk that requires premarket approval | 212 |