Duns Number:961027315
Device Description: SmartSleeve Impervious Surgical Gown, Large
Catalog Number
C9011
Brand Name
CONVERTORS
Version/Model Number
C9011
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
February 26, 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
FYA
Product Code Name
GOWN, SURGICAL
Public Device Record Key
7c794b68-1ec9-4e46-be18-1ffa464f23bc
Public Version Date
February 28, 2022
Public Version Number
7
DI Record Publish Date
June 22, 2016
Package DI Number
50885380119949
Quantity per Package
20
Contains DI Package
10885380119941
Package Discontinue Date
February 26, 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 |