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Paxman Accessories

FDA UDI

Class II (US FDA UDI)

by Paxman Coolers Limited

Identity

Trade Name
Paxman Accessories FDA UDI
Generic Name
Scalp cooling system, hair loss FDA UDI
Device Name
Accessory items used to support the use of the PSCS device. FDA UDI
Model / Reference
Accessories Pack FDA UDI
Description
Accessory items used to support the use of the PSCS device. FDA UDI

Identifiers

Catalog Number
Accessories Pack FDA UDI
Primary DI / UDI-DI
B561ACCESSORIES2 FDA UDI
510(k) Number
K163484 FDA UDI
K173032 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
Not 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

Paxman Accessories by Paxman Coolers Limited — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K163484 also covers:

K173032 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Paxman Coolers Limited

Sources (1)

  • FDA UDI 46741692-1c07-4ee8-ac94-9205d0166633 37 fields · synced May 30, 2026