Duns Number:961027315
Device Description: Under Buttocks Drape with Fluid Control Pouch
Catalog Number
8461
Brand Name
CONVERTORS
Version/Model Number
8461
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
March 29, 2025
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
151244d6-a674-407c-b238-c410944e08b7
Public Version Date
May 06, 2022
Public Version Number
6
DI Record Publish Date
July 24, 2019
Package DI Number
50192253018903
Quantity per Package
20
Contains DI Package
00192253018908
Package Discontinue Date
March 28, 2025
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 |