Identity
- Trade Name
- Flora™ Tissue Expander SMOOTHSILK® FDA UDI
- Generic Name
- Skin-port tissue expander FDA UDI
- Device Name
- Flora™ Tissue Expander SMOOTHSILK® Motiva® Flora® SmoothSilk Tissue Expander - Corsé Medium Height 490cc FDA UDI
- Model / Reference
- M-13-490 FDA UDI
- Description
- Flora™ Tissue Expander SMOOTHSILK® Motiva® Flora® SmoothSilk Tissue Expander - Corsé Medium Height 490cc FDA UDI
Identifiers
- Catalog Number
- M-13-490 FDA UDI
- Primary DI / UDI-DI
- 07445161020901 FDA UDI
- 510(k) Number
- K211676 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
Yes
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
Yes
FDA UDI
Dry Heat Sterilization FDA UDI
MR Conditional FDA UDI
Category: Skin-port tissue expander
Flora™ Tissue Expander SMOOTHSILK® by Establishment Labs S.A. — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K211676 also covers:
- Flora™ Tissue Expander SMOOTHSILK® — Establishment Labs S.A.
- Flora™ Tissue Expander SMOOTHSILK® — Establishment Labs S.A.
- Flora™ Tissue Expander SMOOTHSILK® — Establishment Labs S.A.
- Flora™ Tissue Expander SMOOTHSILK® — Establishment Labs S.A.
- Flora™ Tissue Expander SMOOTHSILK® — Establishment Labs S.A.
- Flora™ Tissue Expander SMOOTHSILK® — Establishment Labs S.A.
- Flora™ Tissue Expander SMOOTHSILK® — Establishment Labs S.A.
- Flora™ Tissue Expander SMOOTHSILK® — Establishment Labs S.A.
- Flora™ Tissue Expander SMOOTHSILK® — Establishment Labs S.A.
- Flora™ Tissue Expander SMOOTHSILK® — Establishment Labs S.A.
- Flora™ Tissue Expander SMOOTHSILK® — Establishment Labs S.A.
- Flora™ Tissue Expander SMOOTHSILK® — Establishment Labs S.A.
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
- Establishment Labs S.A.
Sources (1)
- FDA UDI 602483fc-1d1d-4815-a5f6-7351f145ba69 35 fields · synced May 30, 2026