Duns Number:256880576
Device Description: RITMED ASSUREWEAR ISOLATION GOWN M/L Green
Catalog Number
G-8009
Brand Name
RITMED
Version/Model Number
G-8009
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
9ca17d7b-6865-4b4a-bf30-a98ff15429b0
Public Version Date
October 23, 2020
Public Version Number
1
DI Record Publish Date
October 15, 2020
Package DI Number
20686864056793
Quantity per Package
10
Contains DI Package
10686864056796
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
OUTER CASE
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 84 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 27 |
| U | Unclassified | 2 |