Duns Number:078572603
Device Description: Tubular Elastic Support Bandage, 8-1/4” x 11yds, Natural, Size K, Medium Trunks
Catalog Number
-
Brand Name
HCS
Version/Model Number
HCS503418
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
MHW
Product Code Name
Dressing, Compression
Public Device Record Key
63bc3332-c811-4827-b65d-1c0ecceaca53
Public Version Date
September 20, 2021
Public Version Number
2
DI Record Publish Date
May 15, 2020
Package DI Number
10849027004816
Quantity per Package
4
Contains DI Package
00849027004819
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 |