Identity
- Trade Name
- Paxman cap kit FDA UDI
- Generic Name
- Scalp cooling system, hair loss FDA UDI
- Device Name
- Paxman Cooling Cap Kit which consists of a Paxman Cooling Cap, haircare accessories and patient information on scalp cooling. The Paxman Cooling Cap consists of a silicone inner layer and neoprene outer cover that connects to the Paxman Scalp Cooling System (PSCS) to provide scalp cooling treatment. FDA UDI
- Model / Reference
- Medium, 25 credits FDA UDI
- Description
- Paxman Cooling Cap Kit which consists of a Paxman Cooling Cap, haircare accessories and patient information on scalp cooling. The Paxman Cooling Cap consists of a silicone inner layer and neoprene outer cover that connects to the Paxman Scalp Cooling System (PSCS) to provide scalp cooling treatment. FDA UDI
Identifiers
- Catalog Number
- PSCS-KIT-M25 FDA UDI
- Primary DI / UDI-DI
- B561PSCSKITM251 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
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Scalp cooling system, hair loss
Paxman cap kit by Paxman Coolers Limited — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Scalp cooling system, hair loss.
- DigniCap® Delta — Dignitana AB · Class II
- DigniCap® Delta — Dignitana AB · Class II
- DigniCap® Delta — Dignitana AB · Class II
- DigniCap® Delta — Dignitana AB
- DigniCap® Delta — Dignitana AB · Class II
- AMMA — COOLER HEADS CARE, INC. · Class II
- DigniCap® Delta — Dignitana AB · Class II
- DigniCap® Delta — Dignitana AB · Class II
Cleared under the same submission
K163484 also covers:
- PSCS — PAXMAN COOLERS LIMITED
- PSCS — PAXMAN COOLERS LIMITED
- PSCS Coolant — PAXMAN COOLERS LIMITED
- PSCS Coolant — PAXMAN COOLERS LIMITED
- PSCS Coolant — PAXMAN COOLERS LIMITED
- PSCS Coolant — PAXMAN COOLERS LIMITED
- Paxman Cooling Cap — PAXMAN COOLERS LIMITED
- Paxman Cooling Cap — PAXMAN COOLERS LIMITED
- Paxman Cooling Cap — PAXMAN COOLERS LIMITED
- Paxman Cooling Cap — PAXMAN COOLERS LIMITED
- Paxman Cooling Cap — PAXMAN COOLERS LIMITED
- Paxman Cooling Cap — PAXMAN COOLERS LIMITED
K173032 also covers:
- PSCS — PAXMAN COOLERS LIMITED
- PSCS — PAXMAN COOLERS LIMITED
- PSCS Coolant — PAXMAN COOLERS LIMITED
- PSCS Coolant — PAXMAN COOLERS LIMITED
- PSCS Coolant — PAXMAN COOLERS LIMITED
- PSCS Coolant — PAXMAN COOLERS LIMITED
- Paxman Cooling Cap — PAXMAN COOLERS LIMITED
- Paxman Cooling Cap — PAXMAN COOLERS LIMITED
- Paxman Cooling Cap — PAXMAN COOLERS LIMITED
- Paxman Cooling Cap — PAXMAN COOLERS LIMITED
- Paxman Cooling Cap — PAXMAN COOLERS LIMITED
- Paxman Cooling Cap — PAXMAN COOLERS LIMITED
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Paxman Coolers Limited
Sources (1)
- FDA UDI 5f33e05b-ae74-4722-b116-30de1dffeced 36 fields · synced Jun 8, 2026