Duns Number:025460908
Device Description: TRAY,IRRIGATION,PISTON SYRINGE,60ML
Catalog Number
DYND20300
Brand Name
Medline
Version/Model Number
DYND20300
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
f4e66eca-ce52-4df2-89aa-eff3b7b70d8f
Public Version Date
June 10, 2022
Public Version Number
2
DI Record Publish Date
January 05, 2021
Package DI Number
40080196031796
Quantity per Package
20
Contains DI Package
10080196031795
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CASE
| 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 |