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SIENTRA Anatomical Controlled Tissue Expander (ACX)
FDA UDIClass U (US FDA UDI)
Identity
- Trade Name
- SIENTRA Anatomical Controlled Tissue Expander (ACX) FDA UDI
- Generic Name
- Skin-port tissue expander FDA UDI
- Device Name
- Anatomical Controlled Tissue Expander, Double Chamber, ACX, 390 cc FDA UDI
- Model / Reference
- 20799-390ACX FDA UDI
- Description
- Anatomical Controlled Tissue Expander, Double Chamber, ACX, 390 cc FDA UDI
Identifiers
- Catalog Number
- 20799-390ACX FDA UDI
- Primary DI / UDI-DI
- 00812790022250 FDA UDI
- 510(k) Number
- K981852 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
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
SIENTRA Anatomical Controlled Tissue Expander (ACX) by Sientra, Inc. — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 |
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Manufacturer
- Manufacturer
- Sientra, Inc.
Sources (1)
- FDA UDI f88c47d7-c5ea-4e18-8352-c70956861682 38 fields · synced Jun 8, 2026