Duns Number:006999858
Device Description: Fenestrated Heart Drape, 1 Ply White T180 Drape, 1 Ply 15" x 15" Ceil Barrier Supreme Rei Fenestrated Heart Drape, 1 Ply White T180 Drape, 1 Ply 15" x 15" Ceil Barrier Supreme Reinforcement Pad, 7 1/2" Square Fenestration, Concealed Hems Around Reinforcement Pad
Catalog Number
96617530
Brand Name
Fenestrated Heart Drape
Version/Model Number
96617530
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
-
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
8ddd6752-228e-41a7-9bf9-45fb04480e9a
Public Version Date
February 05, 2021
Public Version Number
2
DI Record Publish Date
April 03, 2020
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 | 26 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 9 |