Duns Number:008124539
Device Description: Irrigation Tray with 60cc Piston Syringe: 800cc Outer Basin Tray, 500cc Plastic Graduate, Irrigation Tray with 60cc Piston Syringe: 800cc Outer Basin Tray, 500cc Plastic Graduate, Irrigation Piston Syringe, Protective Cap, Waterproof Drape, Antiseptic Wipe
Catalog Number
-
Brand Name
Irrigation Tray with 60cc Piston Syringe
Version/Model Number
4268
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
f9578ea6-9267-4273-b9c2-c6c1c430197a
Public Version Date
June 29, 2021
Public Version Number
1
DI Record Publish Date
June 21, 2021
Package DI Number
00616784426839
Quantity per Package
20
Contains DI Package
00616784426822
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 | 694 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 226 |
| 3 | A medical device with high risk that requires premarket approval | 2 |