Duns Number:096372255
Device Description: STERILE AERO BLUE CHROME GOWN AAMI3
Catalog Number
32-2175
Brand Name
DeRoyal
Version/Model Number
32-2175
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K070431,K070431
Product Code
FYA
Product Code Name
GOWN, SURGICAL
Public Device Record Key
5385133f-6cd8-478d-979c-56bc5453683e
Public Version Date
August 31, 2021
Public Version Number
1
DI Record Publish Date
August 23, 2021
Package DI Number
50749756354788
Quantity per Package
25
Contains DI Package
00749756354783
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 | 7041 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 4913 |
| U | Unclassified | 3 |