Aequalis

FDA UDI

Class II (US FDA UDI)

by Tornier, Inc.

Identity

Trade Name: AEQUALIS FDA UDI
Generic Name: Stem-fixed metallic humeral head prosthesis FDA UDI
Model / Reference: DWB243 FDA UDI

Identifiers

Catalog Number: DWB243 FDA UDI
Primary DI / UDI-DI: 03700386915529 FDA UDI
FDA Product Code: KWS FDA UDI
GMDN Term: Stem-fixed metallic humeral head prosthesis FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 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: Height — 16 Millimeter FDA UDI
Outer Diameter — 43 Millimeter FDA UDI

Category: Stem-fixed metallic humeral head prosthesis

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

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Also classified as Stem-fixed metallic humeral head prosthesis.

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GLOBAL AP — DEPUY ORTHOPAEDICS, INC. · Class II
REUNION — Stryker Corp. · Class II
Anatomical Shoulder™ Domelock® — Zimmer, Inc. · Class II
INTEGRATED SHOULDER SYSTEM — Biomet Orthopedics, Inc. · 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 c91d1d07-5708-4ceb-a353-ab298911a3b4 35 fields · synced May 31, 2026