Duns Number:006999858
Device Description: Reusable Gown, Bound Neck, Neck and Waist Tie Closures, Long Sleeves with White Cuffs, Siz Reusable Gown, Bound Neck, Neck and Waist Tie Closures, Long Sleeves with White Cuffs, Size 3XL
Catalog Number
-
Brand Name
Isolation Gown, Reusable
Version/Model Number
666405F2
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"
-
For Single-Use
-
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
efbea97d-7e19-4f5d-8767-b17cb4da82c4
Public Version Date
July 27, 2020
Public Version Number
1
DI Record Publish Date
July 17, 2020
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 26 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 9 |