Arcadia™

FDA UDI

Class II (US FDA UDI)

by Merit Medical Systems, Inc.

Identity

Trade Name: Arcadia™ FDA UDI
Generic Name: Orthopaedic cement dispenser FDA UDI
Model / Reference: 00884450476864 FDA UDI

Identifiers

Catalog Number: IN55VCF FDA UDI
Primary DI / UDI-DI: 00884450476864 FDA UDI
FDA Product Code: PTM FDA UDI
GMDN Term: Orthopaedic cement dispenser FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.1650 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

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Lot / Batch Number

Yes

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Serial Number

FDA UDI

Expiration Date

Yes

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Manufacturing Date

Yes

FDA UDI

Category: Orthopaedic cement dispenser

Introducing the Arcadia Orthopaedic Cement Dispenser, a precise and efficient device for placing orthopaedic bone cement into surgical sites. This manual or powered unit ensures accurate placement, reducing the risk of complications.

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Also classified as Orthopaedic cement dispenser.

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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 II	Pending data

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Manufacturer

Manufacturer: Merit Medical Systems, Inc.

Sources (1)

FDA UDI 62eea224-162e-4656-aa23-292c1298b6ed 33 fields · synced Jul 24, 2026