Identity
- Trade Name
- Macroplastique Implants FDA UDI
- Generic Name
- Urinary tract reconstructive material, synthetic polymer, non-bioabsorbable FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- MPQ-2.5 FDA UDI
- Description
- 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. FDA UDI
Identifiers
- Catalog Number
- MPQ-2.5 FDA UDI
- Primary DI / UDI-DI
- 08717591240266 FDA UDI
- PMA Number
- P040050 FDA UDI
- FDA Product Code
- LNM FDA UDI
- GMDN Term
- Urinary tract reconstructive material, synthetic polymer, non-bioabsorbable FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Urinary tract reconstructive material, synthetic polymer, non-bioabsorbable
Macroplastique Implants by Uroplasty, LLC — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class III | Pending data |
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Manufacturer
- Manufacturer
- Uroplasty, LLC
Sources (1)
- FDA UDI 66972483-3f68-455b-89d7-703ae0c52d03 35 fields · synced May 30, 2026