Duns Number:256880576
Device Description: AMD-RITMED NON-WOVEN ISLAND DRESSING 6 X 6 Inch
Catalog Number
A50066
Brand Name
AMD-RITMED
Version/Model Number
A50066
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
January 25, 2019
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
KGX
Product Code Name
Tape and bandage, adhesive
Public Device Record Key
6cd7a17e-44d6-45cc-8f28-494cb64f4948
Public Version Date
June 19, 2020
Public Version Number
2
DI Record Publish Date
January 13, 2019
Package DI Number
12686864051218
Quantity per Package
15
Contains DI Package
10686864051210
Package Discontinue Date
January 25, 2019
Package Status
Not in Commercial Distribution
Package Type
Inner Box
| 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 |