Duns Number:961027315
Device Description: Novaplus; Over the Head Isolation Gown with Thumbhooks and Elastic Wrists; Yellow; Univers Novaplus; Over the Head Isolation Gown with Thumbhooks and Elastic Wrists; Yellow; Universal Size
Catalog Number
V3110PG
Brand Name
NOVAPLUS
Version/Model Number
V3110PG
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
November 13, 2023
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
40b9df33-c00a-4508-be40-212fff02f1b7
Public Version Date
December 21, 2020
Public Version Number
2
DI Record Publish Date
June 05, 2019
Package DI Number
50885380114692
Quantity per Package
10
Contains DI Package
30885380114698
Package Discontinue Date
November 12, 2023
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 |