Duns Number:256880576
Device Description: AMD-RITMED FABRIC ADHESIVE BANDAGES 2 X 4 Inch
Catalog Number
AF0402
Brand Name
AMD-RITMED
Version/Model Number
AF0402
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
KGX
Product Code Name
Tape and bandage, adhesive
Public Device Record Key
124a5a9e-d30c-45d6-a2b4-23c2893f8770
Public Version Date
August 07, 2020
Public Version Number
3
DI Record Publish Date
January 16, 2019
Package DI Number
20686864052702
Quantity per Package
24
Contains DI Package
10686864052705
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 |