Duns Number:256880576
Device Description: AMD-RITMED COUNTWAY SYSTEM PANEL WITH POCKETS
Catalog Number
2213-BL
Brand Name
AMD-RITMED
Version/Model Number
2213-BL
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
LWH
Product Code Name
Counter, sponge, surgical
Public Device Record Key
ed0622e6-472b-47d5-8a58-2fd0df7692f4
Public Version Date
July 29, 2022
Public Version Number
3
DI Record Publish Date
January 16, 2019
Package DI Number
20686864048033
Quantity per Package
8
Contains DI Package
10686864048036
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 |