Duns Number:961027315
Device Description: Clear Cover
Catalog Number
D2007
Brand Name
CONVERTORS
Version/Model Number
D2007
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
August 06, 2021
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
KKX
Product Code Name
Drape, surgical
Public Device Record Key
b3e19b92-5b16-4af3-a2f5-7fd1f1244465
Public Version Date
December 22, 2021
Public Version Number
8
DI Record Publish Date
July 13, 2016
Package DI Number
50885380069466
Quantity per Package
30
Contains DI Package
10885380069468
Package Discontinue Date
August 06, 2021
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 |