Identity
- Trade Name
- MENTOR MemoryShape Breast Implant FDA UDI
- Generic Name
- Silicone gel-filled breast implant, textured-surface FDA UDI
- Device Name
- Low Height, Moderate Plus Profile Silicone Gel-Filled Breast Implant, 195cc |Textured|Contour|Silicone| FDA UDI
- Model / Reference
- 3341057 FDA UDI
- Description
- Low Height, Moderate Plus Profile Silicone Gel-Filled Breast Implant, 195cc |Textured|Contour|Silicone| FDA UDI
Identifiers
- Catalog Number
- 334-1057 FDA UDI
- Primary DI / UDI-DI
- 00081317004905 FDA UDI
- PMA Number
- P060028 FDA UDI
- FDA Product Code
- FTR FDA UDI
- GMDN Term
- Silicone gel-filled breast implant, textured-surface FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Regulation Number
- 878.3540 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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Silicone gel-filled breast implant, textured-surface
MENTOR MemoryShape Breast Implant by Mentor Texas LP — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Silicone gel-filled breast implant, textured-surface.
- Silicone Gel Breast Implant — Sientra, Inc. · Class III
- OPUS Silicone Gel Breast Implant — Sientra, Inc. · Class III
- Silicone Gel Sizer — Sientra, Inc. · Class III
- SIENTRA Silicone Gel Breast Implant — Sientra, Inc. · Class III
- Silicone Gel Breast Implant — Sientra, Inc. · Class III
- SIENTRA Silicone Gel Breast Implant — Sientra, Inc. · Class III
- Silicone Gel Sizer — Sientra, Inc. · Class III
- Silicone Gel Breast Implant — Sientra, Inc. · Class III
Cleared under the same submission
P060028 also covers:
- MENTOR MemoryShape Breast Implant — Mentor Texas LP
- MENTOR MemoryShape Breast Implant — Mentor Texas LP
- MENTOR MemoryShape Breast Implant — Mentor Texas LP
- MENTOR MemoryShape Breast Implant — Mentor Texas LP
- MENTOR MemoryShape Breast Implant — Mentor Texas LP
- MENTOR MemoryShape Breast Implant — Mentor Texas LP
- MENTOR MemoryShape Breast Implant — Mentor Texas LP
- MENTOR MemoryShape Breast Implant — Mentor Texas LP
- MENTOR MemoryShape Breast Implant — Mentor Texas LP
- MENTOR MemoryShape Breast Implant — Mentor Texas LP
- MENTOR MemoryShape Breast Implant — Mentor Texas LP
- MENTOR MemoryShape Breast Implant — 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 d7cdbec6-5902-4a0a-9cc1-87b4cf401ca2 36 fields · synced May 31, 2026