Duns Number:961027315
Device Description: Cardiovascular Split Drape II, Optima
Catalog Number
9158
Brand Name
CONVERTORS
Version/Model Number
9158
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
September 21, 2023
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
625af86d-6a0c-4bb0-9302-b2697a1502a0
Public Version Date
December 22, 2021
Public Version Number
7
DI Record Publish Date
June 22, 2016
Package DI Number
50630140934788
Quantity per Package
8
Contains DI Package
00630140030690
Package Discontinue Date
September 20, 2023
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 |