Duns Number:831375089
Device Description: PremierPro Chemo Tested Cover Gown Universal 10/bg
Catalog Number
2372
Brand Name
PremierPro
Version/Model Number
2372
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)
-
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
5a9621cc-a776-47d9-99ad-a9bb74cfa2f2
Public Version Date
May 25, 2021
Public Version Number
1
DI Record Publish Date
May 17, 2021
Package DI Number
10811220033474
Quantity per Package
5
Contains DI Package
00811220033477
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 | 486 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 177 |
| U | Unclassified | 1 |