Duns Number:121788819
Device Description: COVAIRE BARRIER DRAPEAEROSOL CONTAINMENT DRAPE, CLEAR, UNIV 100/CS
Catalog Number
7389-CLDR
Brand Name
COVAIRE
Version/Model Number
7389-CLDR
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)
Yes
Over the Counter (OTC)
-
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
9a08ca45-ad03-4095-9632-287ceb03d47b
Public Version Date
December 22, 2021
Public Version Number
2
DI Record Publish Date
March 20, 2021
Package DI Number
50612899239680
Quantity per Package
100
Contains DI Package
00612899239685
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CA
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 112 |