Duns Number:256880576
Device Description: AMD-RITMED OVAL EYE PAD 2 1/8 X 2 5/8 Inch
Catalog Number
A1111
Brand Name
AMD-RITMED
Version/Model Number
A1111
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
HMP
Product Code Name
PAD, EYE
Public Device Record Key
3473501d-57f9-450d-a0d9-cdb1c57ce5e7
Public Version Date
March 21, 2019
Public Version Number
2
DI Record Publish Date
January 14, 2019
Package DI Number
12686864050297
Quantity per Package
50
Contains DI Package
10686864050299
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Tray
| 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 |