Duns Number:112164780
Device Description: Isolation Gown Yellow X-Large SMS
Catalog Number
V2101PG
Brand Name
NOVAPLUS
Version/Model Number
V2101PG
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
OEA
Product Code Name
Non-surgical isolation gown
Public Device Record Key
c457b15b-406e-4563-a509-b58431b312ae
Public Version Date
August 12, 2019
Public Version Number
1
DI Record Publish Date
August 02, 2019
Package DI Number
50885380151567
Quantity per Package
10
Contains DI Package
20885380151566
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 | 81 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 111 |