Duns Number:961027315
Device Description: CV Incise Sheet
Catalog Number
9156
Brand Name
CONVERTORS
Version/Model Number
9156
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 30, 2022
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
2b11fd38-4137-4f65-b31d-f56000eeed8b
Public Version Date
October 31, 2022
Public Version Number
10
DI Record Publish Date
June 22, 2016
Package DI Number
50630140030688
Quantity per Package
7
Contains DI Package
00630140030683
Package Discontinue Date
July 23, 2022
Package Status
Not 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 |