Identity
- Trade Name
- COUPLING FLUID FDA UDI
- Generic Name
- Radio-frequency skin/body contouring system FDA UDI
- Device Name
- Viveve Coupling Fluid, 30ml bottle, each FDA UDI
- Model / Reference
- VIVCF02 FDA UDI
- Description
- Viveve Coupling Fluid, 30ml bottle, each FDA UDI
Identifiers
- Catalog Number
- VIVCF02 FDA UDI
- Primary DI / UDI-DI
- 00850794007071 FDA UDI
- 510(k) Number
- K082962 FDA UDI
- FDA Product Code
- GEI FDA UDI
- GMDN Term
- Radio-frequency skin/body contouring system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4400 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Radio-frequency skin/body contouring system
Coupling Fluid by Viveve, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K082962 also covers:
- 5 cm Treatment Tip — VIVEVE, INC.
- 5 cm Treatment Tip S — VIVEVE, INC.
- 8 cm Treatment Tip — VIVEVE, INC.
- CRYOGEN CANISTER — VIVEVE, INC.
- Universal Electrosurgical Pad (3M REF 9160) — VIVEVE, INC.
- VIVEVE Console — VIVEVE, INC.
- VIVEVE Console S — VIVEVE, INC.
- VIVEVE Footswitch — VIVEVE, INC.
- VIVEVE Hand Piece — VIVEVE, INC.
- VIVEVE Hand Piece S — VIVEVE, INC.
- VIVEVE Power Cord — VIVEVE, INC.
- VIVEVE Return Cable — VIVEVE, INC.
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 II | Pending data |
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Manufacturer
- Manufacturer
- Viveve, Inc.
Sources (1)
- FDA UDI 59a95c55-3943-4d4e-8684-04c24d43db1a 35 fields · synced May 31, 2026