Duns Number:961027315
Device Description: SmartSleeve Surgical Gown, XL. Polyreinforced Surgical Gown
Catalog Number
9041
Brand Name
CONVERTORS
Version/Model Number
9041
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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
32c0fe0e-8e07-4141-86aa-677b903e3655
Public Version Date
April 07, 2021
Public Version Number
4
DI Record Publish Date
December 14, 2018
Package DI Number
50885380156067
Quantity per Package
20
Contains DI Package
10885380156069
Package Discontinue Date
-
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 |