Duns Number:006999858
Device Description: EasyRelease, Generic Polyester Isolation Gown, Bound Neck, Velcro Hook & Loop Closures at EasyRelease, Generic Polyester Isolation Gown, Bound Neck, Velcro Hook & Loop Closures at Neck/Waist, Long Sleeves with Natural White, Size XL, AP7036 Non-Linting Cuffs and Cuff Shields
Catalog Number
-
Brand Name
Generic Polyester Isolation Gown
Version/Model Number
661Y4974
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
bf926ea9-0929-430c-9d1c-2a24e957dfa8
Public Version Date
June 21, 2021
Public Version Number
1
DI Record Publish Date
June 11, 2021
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 |