Duns Number:961027315
Device Description: Femoral Angiography Drape with Pouch
Catalog Number
29525
Brand Name
CONVERTORS
Version/Model Number
29525
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)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
PUI
Product Code Name
Drape, surgical, exempt
Public Device Record Key
2a16bae7-7177-4195-8fe7-3396438a9fa1
Public Version Date
October 03, 2022
Public Version Number
4
DI Record Publish Date
July 13, 2016
Package DI Number
50885380035447
Quantity per Package
10
Contains DI Package
00885380035442
Package Discontinue Date
-
Package Status
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 |