Duns Number:078572603
Device Description: Impervious Gown, PE, Blue, X-Large, Thumb Loop, Tie Waist, Over the Head Neck, Latex Free
Catalog Number
-
Brand Name
HCS
Version/Model Number
HCS3002XL
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"
Yes
For Single-Use
Yes
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
0871e59b-b3ca-466c-ae90-4024b2287945
Public Version Date
January 08, 2020
Public Version Number
1
DI Record Publish Date
December 31, 2019
Package DI Number
10849027003444
Quantity per Package
5
Contains DI Package
00849027003447
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CASE
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 72 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 30 |