Duns Number:256880576
Device Description: AMD-RITMED NON-WOVEN ISLAND DRESSING 4 X 4 Inch
Catalog Number
A50044
Brand Name
AMD-RITMED
Version/Model Number
A50044
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
February 02, 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
8881e09d-8e0c-41c9-a940-b46fa7a02780
Public Version Date
June 19, 2020
Public Version Number
2
DI Record Publish Date
January 13, 2019
Package DI Number
20686864051200
Quantity per Package
10
Contains DI Package
12686864051201
Package Discontinue Date
February 02, 2019
Package Status
Not 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 |