Duns Number:256880576
Device Description: AMD-RITMED SOLON RAYON TIPPED PROCTOSCOPIC APPLICATORS 16 Inch
Catalog Number
57500
Brand Name
AMD-RITMED SOLON
Version/Model Number
57500
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
KXF
Product Code Name
APPLICATOR, ABSORBENT TIPPED, NON-STERILE
Public Device Record Key
9c5d2913-4aae-4de4-9079-04de8048571b
Public Version Date
May 03, 2022
Public Version Number
2
DI Record Publish Date
January 14, 2019
Package DI Number
20686864046039
Quantity per Package
10
Contains DI Package
10686864046032
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 |