Identity
- Trade Name
- CoolGel Max FDA UDI
- Generic Name
- Cryolipolysis body contouring system gel pad FDA UDI
- Device Name
- CoolGel Max, Qty 8 FDA UDI
- Model / Reference
- BRZ-PD1-08X-008 FDA UDI
- Description
- CoolGel Max, Qty 8 FDA UDI
Identifiers
- Catalog Number
- BRZ-PD1-08X-008 FDA UDI
- Primary DI / UDI-DI
- 10816417020695 FDA UDI
- FDA Product Code
- OOK FDA UDI
- GMDN Term
- Cryolipolysis body contouring system gel pad FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4340 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: Cryolipolysis body contouring system gel pad
CoolGel Max by Zeltiq Aesthetics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cryolipolysis body contouring system gel pad.
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- CoolAdhesive Plus Pad — Zeltiq Aesthetics, Inc. · Class II
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
- Zeltiq Aesthetics, Inc.
Sources (1)
- FDA UDI d553db04-0945-45f0-a339-f55884862f9b 35 fields · synced Jun 8, 2026