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MENTOR Injection Domes with Stainless Steel TRUE LOCK Connection Systems
FDA UDIClass III (US FDA UDI)
Identity
- Trade Name
- MENTOR Injection Domes with Stainless Steel TRUE LOCK Connection Systems FDA UDI
- Generic Name
- Saline-filled breast implant, unstructured, smooth-surface FDA UDI
- Device Name
- Dome Pack FDA UDI
- Model / Reference
- 350-DOMPK FDA UDI
- Description
- Dome Pack FDA UDI
Identifiers
- Catalog Number
- 350-DOMPK FDA UDI
- Primary DI / UDI-DI
- 00081317004059 FDA UDI
- PMA Number
- P990075 FDA UDI
- FDA Product Code
- FWM FDA UDI
- GMDN Term
- Saline-filled breast implant, unstructured, smooth-surface FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Regulation Number
- 878.3530 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
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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Saline-filled breast implant, unstructured, smooth-surface
MENTOR Injection Domes with Stainless Steel TRUE LOCK Connection Systems by Mentor Texas LP — Class III — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as Saline-filled breast implant, unstructured, smooth-surface.
- NATRELLE Saline-Filled Breast Implants — Allergan · Class III
- NATRELLE Saline-Filled Breast Implants — Allergan · Class III
- NATRELLE Saline-Filled Breast Implants — Allergan · Class III
- NATRELLE Saline-Filled Breast Implants — Allergan · Class III
- NATRELLE Saline-Filled Breast Implants — Allergan · Class III
- NATRELLE Saline-Filled Breast Implants — Allergan · Class III
- NATRELLE Saline-Filled Breast Implants — Allergan · Class III
- NATRELLE Saline-Filled Breast Implants — Allergan · Class III
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 7aaa39f3-2abd-4d32-b1d6-62554f58d909 36 fields · synced May 30, 2026