Identity
- Trade Name
- MENTOR CPX 2 Breast Tissue Expander FDA UDI
- Generic Name
- Skin-port tissue expander FDA UDI
- Device Name
- SITLEX Medium Height Tissue Expander Style 6200, 550cc FDA UDI
- Model / Reference
- 3546214 FDA UDI
- Description
- SITLEX Medium Height Tissue Expander Style 6200, 550cc FDA UDI
Identifiers
- Catalog Number
- 354-6214 FDA UDI
- Primary DI / UDI-DI
- 00081317002277 FDA UDI
- 510(k) Number
- K011500 FDA UDI
- FDA Product Code
- LCJ FDA UDI
- GMDN Term
- Skin-port tissue expander FDA UDI
Classification
- Device Class
- U FDA UDI
- Commercial Distribution
- Not 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
MENTOR CPX 2 Breast Tissue Expander by Mentor Texas LP — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K011500 also covers:
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 54dbb2f6-fc82-4f34-8f9f-d4ef16dcf1e5 37 fields · synced Jun 8, 2026