Identity
- Trade Name
- PSCS Coolant FDA UDI
- Generic Name
- Scalp cooling system, hair loss FDA UDI
- Device Name
- A consumable component of the Paxman Scalp Cooling System (PSCS) used as the cooling solution that is circulated within the system. This pack of coolant is used for commissioning the system. FDA UDI
- Model / Reference
- Comm Pack FDA UDI
- Description
- A consumable component of the Paxman Scalp Cooling System (PSCS) used as the cooling solution that is circulated within the system. This pack of coolant is used for commissioning the system. FDA UDI
Identifiers
- Catalog Number
- 300-16-03 FDA UDI
- Primary DI / UDI-DI
- B561COOLANTCOMMPACK1 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
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Scalp cooling system, hair loss
PSCS Coolant by Paxman Coolers Limited — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- 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
- 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
- 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
- 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 |
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Manufacturer
- Manufacturer
- Paxman Coolers Limited
Sources (1)
- FDA UDI b6f2d94c-fd47-408b-b7bb-a11fb6241177 36 fields · synced May 30, 2026