Duns Number:801895244
Device Description: IRRIJET® Single-Use WITH SPLATTER-GARD AND 35 CC SYRINGE WOUND IRRIGATION SYSTEM
Catalog Number
-
Brand Name
IRRIJET® Single-Use
Version/Model Number
55-2134
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
8316eadc-9a7d-4e1c-814a-f0aac5d4e9ff
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 14, 2017
Package DI Number
30888937015950
Quantity per Package
4
Contains DI Package
20888937015953
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 | 29 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1471 |
| 3 | A medical device with high risk that requires premarket approval | 2 |