Identity
- Trade Name
- MENTOR SILTEX CONTOUR PROFILE SPECTRUM FDA UDI
- Generic Name
- Saline-filled breast implant, unstructured, textured-surface FDA UDI
- Device Name
- Post Operatively Adjustable Saline Breast Implant, 550cc FDA UDI
- Model / Reference
- 3542514 FDA UDI
- Description
- Post Operatively Adjustable Saline Breast Implant, 550cc FDA UDI
Identifiers
- Catalog Number
- 354-2514 FDA UDI
- Primary DI / UDI-DI
- 00081317002161 FDA UDI
- PMA Number
- P990075 FDA UDI
- FDA Product Code
- FWM FDA UDI
- GMDN Term
- Saline-filled breast implant, unstructured, textured-surface FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Regulation Number
- 878.3530 FDA UDI
- Commercial Distribution
- Not 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
Yes
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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Mentor Siltex Contour Profile Spectrum by Mentor Texas LP — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
P990075 also covers:
- MENTOR Diaphragm Valve Fill Tube — Mentor Texas LP
- MENTOR Diaphragm Valve Fill Tube LONG 61cm 24in — Mentor Texas LP
- MENTOR Diaphragm Valve Fill Tube LONG 61cm 24in with 45 Degree Connector — Mentor Texas LP
- MENTOR Smooth Round High Profile — Mentor Texas LP
- MENTOR Smooth Round High Profile — Mentor Texas LP
- MENTOR Smooth Round High Profile — Mentor Texas LP
- MENTOR Smooth Round High Profile — Mentor Texas LP
- MENTOR Smooth Round High Profile — Mentor Texas LP
- MENTOR Smooth Round High Profile — Mentor Texas LP
- MENTOR Smooth Round High Profile — Mentor Texas LP
- MENTOR Smooth Round Moderate Plus Profile — Mentor Texas LP
- MENTOR Smooth Round Moderate Plus Profile — Mentor Texas LP
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Mentor Texas LP
Sources (1)
- FDA UDI 8b270860-b7df-4430-9426-c1584340df17 37 fields · synced Jun 8, 2026