Duns Number:063519193
Device Description: Precision Surgical Urology Drain Bags Vinyl Sterile Fits Hoop Style Urology Frames 20 per Precision Surgical Urology Drain Bags Vinyl Sterile Fits Hoop Style Urology Frames 20 per Case
Catalog Number
-
Brand Name
Precision Surgical
Version/Model Number
26676
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
MMZ
Product Code Name
Table, Cystometric, Electric
Public Device Record Key
ed26a500-30b0-40ea-8b09-5f4dff03e202
Public Version Date
October 04, 2022
Public Version Number
1
DI Record Publish Date
September 26, 2022
Package DI Number
10618125167903
Quantity per Package
20
Contains DI Package
00618125167906
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| 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 |