Radiesse

FDA UDI

Class III (US FDA UDI)

by Fcl Health Solutions Ltd

Identity

Trade Name: Radiesse FDA UDI
Generic Name: Synovial fluid supplementation medium FDA UDI
Model / Reference: NA FDA UDI

Identifiers

Primary DI / UDI-DI: 05060432190033 FDA UDI
FDA Product Code: PKY FDA UDI
LMH FDA UDI
GMDN Term: Synovial fluid supplementation medium FDA UDI

Classification

Device Class: Class III FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Synovial fluid supplementation medium

Radiesse by Fcl Health Solutions Ltd — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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 III	Pending data

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Manufacturer

Manufacturer: Fcl Health Solutions Ltd

Sources (1)

FDA UDI 742b99db-bc2b-406f-b861-548f62adcca9 33 fields · synced Jun 8, 2026