Duns Number:961027315
Device Description: IMPERVIOUS STOCKINETTE 6IN X 30IN SMALL 30/CS GAMMA
Catalog Number
1584CE
Brand Name
CONVERTORS
Version/Model Number
1584CE
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
May 22, 2018
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
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
3efdea12-c7c3-489a-935b-b43447dc781d
Public Version Date
December 22, 2021
Public Version Number
5
DI Record Publish Date
May 09, 2018
Package DI Number
50630140031531
Quantity per Package
30
Contains DI Package
00630140031536
Package Discontinue Date
May 22, 2018
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 |