Duns Number:025460908
Device Description: SET,IRRIGATION,CYSTO,Y-TYPE,90"
Catalog Number
DYND19122
Brand Name
Medline
Version/Model Number
DYND19122
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KYZ
Product Code Name
SYRINGE, IRRIGATING (NON DENTAL)
Public Device Record Key
9f53a114-6603-490a-9e72-ff688a490287
Public Version Date
June 10, 2022
Public Version Number
2
DI Record Publish Date
November 12, 2020
Package DI Number
40080196993827
Quantity per Package
20
Contains DI Package
10080196993826
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 38540 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 85094 |
| 3 | A medical device with high risk that requires premarket approval | 2 |
| U | Unclassified | 7 |