Duns Number:069936106
Device Description: Gown, Isolation, S 20-Pk NS
Catalog Number
129059
Brand Name
NOVO Health Services, LLC
Version/Model Number
129059
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 20, 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"
-
For Single-Use
-
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
-
Product Code
OEA
Product Code Name
Non-Surgical Isolation Gown
Public Device Record Key
030f3bb8-461f-4a28-87d7-b443e542ec38
Public Version Date
October 21, 2022
Public Version Number
3
DI Record Publish Date
July 30, 2020
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 226 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 859 |