Identity
- Trade Name
- MENTOR CPX 4 Breast Tissue Expander FDA UDI
- Generic Name
- Skin-port tissue expander FDA UDI
- Device Name
- SILTEX Medium Height Tissue Expander Style 8200, 450cc FDA UDI
- Model / Reference
- 3548213 FDA UDI
- Description
- SILTEX Medium Height Tissue Expander Style 8200, 450cc FDA UDI
Identifiers
- Catalog Number
- 354-8213 FDA UDI
- Primary DI / UDI-DI
- 00081317006541 FDA UDI
- 510(k) Number
- K130813 FDA UDI
- FDA Product Code
- LCJ FDA UDI
- GMDN Term
- Skin-port tissue expander 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
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
MR Unsafe FDA UDI
Category: Skin-port tissue expander
MENTOR CPX 4 Breast Tissue Expander by Mentor Texas LP — Class U — FDA UDI — listed in FDA GUDID — 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
K130813 also covers:
- MENTOR CENTERSCOPE Magnetic Detection Device — 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 (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 U | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Mentor Texas LP
Sources (1)
- FDA UDI 66d865b6-8fcb-4fe4-90f4-56b038bce2d1 36 fields · synced May 30, 2026