Duns Number:063519193
Device Description: Maquet Medical Systems Ins. Urology Drain Bags Vinyl Sterile Fits Hoop Style Urology Frame Maquet Medical Systems Ins. Urology Drain Bags Vinyl Sterile Fits Hoop Style Urology Frames 10 per Case
Catalog Number
-
Brand Name
Maquet Medical Systems Ins.
Version/Model Number
26191
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
September 22, 2022
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
MMZ
Product Code Name
TABLE, CYSTOMETRIC, ELECTRIC
Public Device Record Key
88514ae8-3aa2-4899-9ebe-5592e395d3a4
Public Version Date
September 23, 2022
Public Version Number
5
DI Record Publish Date
October 12, 2016
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 | 222 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2255 |