Aequalis™ Flex Revive™

FDA UDI

Class II (US FDA UDI)

by Tornier, Inc.

Identity

Trade Name: AEQUALIS™ FLEX REVIVE™ FDA UDI
Generic Name: Uncoated shoulder humeral stem prosthesis FDA UDI
Model / Reference: ARS342009 FDA UDI

Identifiers

Catalog Number: ARS342009 FDA UDI
Primary DI / UDI-DI: 00846832069361 FDA UDI
FDA Product Code: HSD FDA UDI
KWS FDA UDI
PHX FDA UDI
GMDN Term: Uncoated shoulder humeral stem prosthesis FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3690 FDA UDI
888.3660 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

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size: Outer Diameter — 13 Millimeter FDA UDI
Length — 30 Millimeter FDA UDI

Category: Uncoated shoulder humeral stem prosthesis

Aequalis™ Flex Revive™ by Tornier, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Uncoated shoulder humeral stem prosthesis.

Anatomical Shoulder™ — Zimmer, Inc. · Class II
Humelock II Cemented Shoulder System — FX SOLUTIONS · Class II
Bigliani/Flatow® — Zimmer, Inc. · Class II
REUNION — Stryker Corp. · Class II
REUNION — Stryker Corp. · Class II
LINK Embrace Shoulder System — WALDEMAR LINK GmbH & Co. KG · Class II
Anatomical Shoulder™ — Zimmer, Inc. · Class II
Embrace Shoulder System — WALDEMAR LINK GmbH & Co. KG · 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: Tornier, Inc.

Sources (1)

FDA UDI aafe5472-79ca-4315-9470-c1c161cc35f4 35 fields · synced May 31, 2026