Duns Number:961027315
Device Description: Novaplus; Film Gown with Thumbhooks; Open Back; Blue; Universal Size
Catalog Number
V5210PG
Brand Name
NOVAPLUS
Version/Model Number
V5210PG
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
May 21, 2021
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
OEA
Product Code Name
Non-surgical isolation gown
Public Device Record Key
5cbbf6f2-5636-4c8e-b5bd-fc8a3418e879
Public Version Date
May 21, 2021
Public Version Number
4
DI Record Publish Date
January 08, 2019
Package DI Number
50885380114616
Quantity per Package
5
Contains DI Package
20885380114615
Package Discontinue Date
May 21, 2021
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 |