Duns Number:078572603
Device Description: Isolation Gown, Yellow SMS, Barrier Protection Level 2 Material, Overhead w/Thumb Loops, U Isolation Gown, Yellow SMS, Barrier Protection Level 2 Material, Overhead w/Thumb Loops, Universal, Latex Free
Catalog Number
-
Brand Name
HCS
Version/Model Number
HCS3004TL
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)
-
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
4a6b17ab-06e2-4623-a498-53250243240e
Public Version Date
January 08, 2020
Public Version Number
1
DI Record Publish Date
December 31, 2019
Package DI Number
10849027002614
Quantity per Package
10
Contains DI Package
00849027002617
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 |