Duns Number:831375089
Device Description: AAMI 3 Gown, SMS, Tape Tab, Yellow, Universal
Catalog Number
-
Brand Name
PremierPro
Version/Model Number
2360
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)
Yes
Device labeled as "Not made with natural rubber latex"
-
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
FYC
Product Code Name
Gown, Isolation, Surgical
Public Device Record Key
efb90126-3092-4c3f-80e8-72311850a1af
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
February 14, 2017
Package DI Number
10818566010923
Quantity per Package
100
Contains DI Package
00818566010926
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 |