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MENTOR CENTERSCOPE Magnetic Detection Device
FDA UDIEUDAMEDClass U (US FDA UDI)
Identity
- Trade Name
- MENTOR CENTERSCOPE Magnetic Detection Device FDA UDI
- Generic Name
- Tissue expander injection port locator FDA UDI
- Model / Reference
- 350-4402 FDA UDI
Identifiers
- Catalog Number
- 350-4402 FDA UDI
- Primary DI / UDI-DI
- 00081317004042 FDA UDI
- FDA Product Code
- LCJ FDA UDI
- GMDN Term
- Tissue expander injection port locator FDA UDI
Classification
- Device Class
- U FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
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: Tissue expander injection port locator
MENTOR CENTERSCOPE Magnetic Detection Device by Mentor Texas LP — Class U — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Tissue expander injection port locator.
Cleared under the same submission
K130813 also covers:
- MENTOR CPX 4 Breast Tissue Expander — Mentor Texas LP
- MENTOR CPX 4 Breast Tissue Expander — Mentor Texas LP
- MENTOR CPX 4 Breast Tissue Expander — Mentor Texas LP
- MENTOR CPX 4 Breast Tissue Expander — Mentor Texas LP
- MENTOR CPX 4 Breast Tissue Expander — Mentor Texas LP
- MENTOR CPX 4 Breast Tissue Expander — Mentor Texas LP
- MENTOR CPX 4 Breast Tissue Expander — Mentor Texas LP
- MENTOR CPX 4 Breast Tissue Expander — Mentor Texas LP
- MENTOR CPX 4 Breast Tissue Expander — Mentor Texas LP
- MENTOR CPX 4 Breast Tissue Expander — Mentor Texas LP
- MENTOR CPX 4 Breast Tissue Expander — Mentor Texas LP
- MENTOR CPX 4 Breast Tissue Expander — Mentor Texas LP
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class U | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class U | Pending data |
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Manufacturer
- Manufacturer
- Mentor Texas LP
Sources (2)
- FDA UDI dd244a7f-f7b8-4f80-b58c-627419f9294d 35 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 4, 2026