Duns Number:801895244
Device Description: IRRIJET® Z WOUND IRRIGATION SYSTEM WITH ZEROWET® SPLASHSHIELD®
Catalog Number
-
Brand Name
IRRIJET® Z
Version/Model Number
55-2004
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
1ec8e97f-002e-442f-ba6b-0746b2bc7209
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 14, 2017
Package DI Number
20888937015939
Quantity per Package
5
Contains DI Package
60888937015937
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 |