Duns Number:961027315
Device Description: Radial/Femoral Angiography Drape
Catalog Number
29529
Brand Name
CONVERTORS
Version/Model Number
29529
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
July 31, 2021
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)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KKX
Product Code Name
Drape, surgical
Public Device Record Key
fd428e29-15da-48f9-b821-5424e82b5f59
Public Version Date
August 02, 2021
Public Version Number
5
DI Record Publish Date
July 14, 2016
Package DI Number
50885380035454
Quantity per Package
12
Contains DI Package
00885380035459
Package Discontinue Date
July 31, 2021
Package Status
Not in Commercial Distribution
Package Type
CASE
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 101686 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 139430 |
| 3 | A medical device with high risk that requires premarket approval | 8 |
| U | Unclassified | 40 |