Duns Number:961027315
Device Description: Irrigation Tray with Bulb Syringe; 1000mL Bulb Irrigation Peel Lid Tray with 60 cc Syringe
Catalog Number
BIT
Brand Name
CARDINAL HEALTH
Version/Model Number
BIT
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
KDD
Product Code Name
Kit, surgical instrument, disposable
Public Device Record Key
9b7f8064-313b-4488-a438-0390d9534de0
Public Version Date
June 17, 2022
Public Version Number
3
DI Record Publish Date
September 05, 2018
Package DI Number
50885380095762
Quantity per Package
20
Contains DI Package
00885380095767
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 | 101686 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 139430 |
| 3 | A medical device with high risk that requires premarket approval | 8 |
| U | Unclassified | 40 |