Duns Number:078780963
Device Description: Isolation gown, SMS, AAMI Level II, Yellow, Over the Head, Full Coverage, Thumb Loop with Isolation gown, SMS, AAMI Level II, Yellow, Over the Head, Full Coverage, Thumb Loop with Elastic Wrist, Universal
Catalog Number
ICP-8150FC
Brand Name
Protexter
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
701552da-b4ea-4ae2-9044-050f4248a38a
Public Version Date
October 28, 2022
Public Version Number
2
DI Record Publish Date
December 28, 2020
Package DI Number
10813360021595
Quantity per Package
10
Contains DI Package
00813360021598
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 |