Duns Number:792528510
Device Description: Irr/Suct System w/ dual valve handles, complete with 33cm, 10mm and 5mm cannulas, modified Irr/Suct System w/ dual valve handles, complete with 33cm, 10mm and 5mm cannulas, modified suction tube to poole style, but with open distal end
Catalog Number
-
Brand Name
Millennium
Version/Model Number
72-5250015M
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
4169002b-38e8-4091-a7ea-8d3c38c2d2ae
Public Version Date
October 01, 2021
Public Version Number
1
DI Record Publish Date
September 23, 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 |