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MENTOR Tissue Expander
FDA UDIEUDAMEDClass U (US FDA UDI)
Ref 350-4315MModel MENTOR Smooth Tissue Expanders
Identity
- Trade Name
- MENTOR Smooth Crescent Tissue Expander with Remote Injection Dome EUDAMEDMENTOR Tissue Expander FDA UDI
- Generic Name
- Skin-port tissue expander FDA UDI
- Device Name
- MENTOR Smooth Tissue Expanders EUDAMEDSmooth Crescent, 300cc FDA UDI
- Model / Reference
- MENTOR Smooth Tissue Expanders EUDAMED350-4315M EUDAMED3504315M FDA UDI
- Description
- Smooth Crescent, 300cc FDA UDI
Identifiers
- Catalog Number
- 350-4315M FDA UDI
- Primary DI / UDI-DI
- 00081317002512 EUDAMEDFDA UDI
- Basic UDI-DI
- 0081317a0000847 EUDAMED
- 510(k) Number
- K842883 FDA UDI
- FDA Product Code
- LCJ FDA UDI
- EMDN Code
- P900106 SEMILUNAR OR CRESCENT TISSUE EXPANDERS EUDAMED
- GMDN Term
- Skin-port tissue expander FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDU FDA UDI
- Medical Purpose
- The intended purpose of the Mentor Smooth Tissue Expanders is to perform tissue expansion during tissue reconstruction for scar revision and/or tissue defect procedures. EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA 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
Category: Skin-port tissue expander
MENTOR Tissue Expander by Mentor Texas LP — Class U — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Skin-port tissue expander.
- INTEGRA® — Pmt Corp. · U
- INTEGRA® — Pmt Corp. · U
- INTEGRA® — Pmt Corp. · U
- INTEGRA® — Pmt Corp. · U
- Dermaspan Tissue Expander — Sientra, Inc. · U
- INTEGRA® — Pmt Corp. · U
- INTEGRA® — Pmt Corp. · U
- Softspan Tissue Expander — Sientra, Inc. · U
Cleared under the same submission
K842883 also covers:
- MENTOR Tissue Expander — Mentor Texas LP
- MENTOR Tissue Expander — Mentor Texas LP
- MENTOR Tissue Expander — Mentor Texas LP
- MENTOR Tissue Expander — Mentor Texas LP
- MENTOR Tissue Expander — Mentor Texas LP
- MENTOR Tissue Expander — Mentor Texas LP
- MENTOR Tissue Expander — Mentor Texas LP
- MENTOR Tissue Expander — Mentor Texas LP
- MENTOR Tissue Expander — Mentor Texas LP
- MENTOR Tissue Expander — Mentor Texas LP
- MENTOR Tissue Expander — Mentor Texas LP
- MENTOR Tissue Expander — Mentor Texas LP
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | 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 e15da902-9575-496a-9b0b-d7ddfefcb371 36 fields · synced Jul 23, 2026
- EUDAMED 6a4bd7ca-311b-418b-a2c9-fa598b5b3a09 61 fields · synced Jul 23, 2026