Duns Number:078780963
Device Description: Isolation Gown, White, AAMI Level 2, SMS, Over the Head, Full Coverage, Thumbloop, Univers Isolation Gown, White, AAMI Level 2, SMS, Over the Head, Full Coverage, Thumbloop, Universal
Catalog Number
ICP-8700
Brand Name
Protexer
Version/Model Number
1
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
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
2028b9b6-2e96-413e-bd9c-fc5cac491d83
Public Version Date
October 28, 2022
Public Version Number
2
DI Record Publish Date
December 30, 2021
Package DI Number
10813360021618
Quantity per Package
10
Contains DI Package
00813360021611
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Bag
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |