Duns Number:804002665
Device Description: Soft tissue bulking agent indicated for transurethral injection in the treatment of adult Soft tissue bulking agent indicated for transurethral injection in the treatment of adult women diagnosed with stress urinary incontinence primarily due to intrinsic sphincter deficiency.
Catalog Number
MPQ-2.5
Brand Name
Macroplastique Implants
Version/Model Number
MPQ-2.5
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
P040050
Product Code
LNM
Product Code Name
Agent, Bulking, Injectable For Gastro-Urology Use
Public Device Record Key
66972483-3f68-455b-89d7-703ae0c52d03
Public Version Date
July 06, 2018
Public Version Number
4
DI Record Publish Date
June 20, 2014
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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 4 |
| 3 | A medical device with high risk that requires premarket approval | 1 |