Arcadia™

FDA UDI

Class II (US FDA UDI)

by Merit Medical Systems, Inc.

Identity

Trade Name: Arcadia™ FDA UDI
Generic Name: Inflatable bone tamp FDA UDI
Model / Reference: D FDA UDI

Identifiers

Catalog Number: ARC10ST-LK FDA UDI
Primary DI / UDI-DI: 00884450790502 FDA UDI
FDA Product Code: HRX FDA UDI
GMDN Term: Inflatable bone tamp FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.1100 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

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

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

Yes

FDA UDI

Dimensions & Sizes

Size: Balloon Length — 10 Millimeter FDA UDI
Needle Gauge — 10 Gauge FDA UDI

Category: Inflatable bone tamp

Arcadia™ by Merit Medical Systems, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Inflatable bone tamp.

KYPHON Express II Inflatable Bone Tamp — MEDTRONIC SOFAMOR DANEK, INC. · Class II
SpineKure Kyphoplasty System — Hanchang Co., Ltd. · Class II
MEDINAUT Plus Kyphoplasty System — IMEDICOM CO., LTD. · Class II
SYNTH™ PLUS — IMEDICOM CO., LTD. · Class II
KYPHON Xpander™ Inflatable Bone Tamp — MEDTRONIC SOFAMOR DANEK, INC. · Class II
KYPHON® Express™ Inflatable Bone Tamp — MEDTRONIC SOFAMOR DANEK, INC. · Class II
Osseoflex SB Steerable Balloon (8ga/2ml) — Osseon, LLC · Class II
Osseoflex SB Steerable Balloon ( 10 ga/ 4ml) — Osseon, LLC · Class II

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 a9b1a37c-01f5-4178-be9e-ac9dacdf650c 34 fields · synced Jun 9, 2026