Identity
- Trade Name
- AMMA FDA UDI
- Generic Name
- Scalp cooling system, hair loss FDA UDI
- Model / Reference
- Accessory Kit, DTC, Medium FDA UDI
Identifiers
- Catalog Number
- 831185 FDA UDI
- Primary DI / UDI-DI
- 00850051245123 FDA UDI
- 510(k) Number
- K211526 FDA UDI
- FDA Product Code
- PMC FDA UDI
- GMDN Term
- Scalp cooling system, hair loss FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4360 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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Scalp cooling system, hair loss
Amma by Cooler Heads Care, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
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
- Cooler Heads Care, Inc.
Sources (1)
- FDA UDI 354b48b4-3987-40fc-b65f-80dfec941b34 35 fields · synced Jun 8, 2026