Duns Number:078572603
Device Description: Cover Gown, SBPP, Yellow, X-Large, Elastic Cuff, Neck and Waist Ties, Latex Free
Catalog Number
-
Brand Name
HCS
Version/Model Number
HCS3000XL
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
FME
Product Code Name
Gown, Examination
Public Device Record Key
7669938d-63c5-4129-88e3-e138721a2ef6
Public Version Date
September 02, 2020
Public Version Number
2
DI Record Publish Date
December 31, 2019
Package DI Number
10849027001365
Quantity per Package
5
Contains DI Package
50849027001363
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| 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 |