Duns Number:256880576
Device Description: AMD-RITMED VITAL SOFT CONFORMING BANDAGES 3 X 75 Inch
Catalog Number
A6983
Brand Name
AMD-RITMED VITAL SOFT
Version/Model Number
A6983
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
MHW
Product Code Name
DRESSING, COMPRESSION
Public Device Record Key
07077861-f801-4ef9-abac-2f98ae553f96
Public Version Date
December 08, 2021
Public Version Number
3
DI Record Publish Date
January 13, 2019
Package DI Number
20686864051828
Quantity per Package
8
Contains DI Package
10686864051821
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Outer Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 84 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 27 |
| U | Unclassified | 2 |