Duns Number:792528510
Device Description: REUSABLE IRRIGATION/SUCTION SYSTEM WITH DUAL HIGH-VOLUME DOUBLE O-RING ANTI-LEAK TRUMPET V REUSABLE IRRIGATION/SUCTION SYSTEM WITH DUAL HIGH-VOLUME DOUBLE O-RING ANTI-LEAK TRUMPET VALVES, COUNTOURED HANDLE, 5MM & 10MM DIA., 33CM CANNULA
Catalog Number
-
Brand Name
Millennium
Version/Model Number
72-5250030
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"
-
For Single-Use
-
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
GCJ
Product Code Name
Laparoscope, General & Plastic Surgery
Public Device Record Key
3c66eec4-d03b-4d81-9289-9739b747cba4
Public Version Date
January 05, 2022
Public Version Number
1
DI Record Publish Date
December 28, 2021
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 6832 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 9482 |