Duns Number:078780963
Device Description: Open Back Gown - Polycoated, Yellow, Over the Head, Open Back, Thumb Loop and Elastic Wris Open Back Gown - Polycoated, Yellow, Over the Head, Open Back, Thumb Loop and Elastic Wrist, Universal
Catalog Number
ICP-5050Y
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
39e1b385-93d5-48f8-8b2c-5c2eef3fddcf
Public Version Date
October 28, 2022
Public Version Number
2
DI Record Publish Date
November 02, 2021
Package DI Number
10813360021533
Quantity per Package
10
Contains DI Package
00813360021536
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 |