Aequalis Resurfacing Head

FDA UDI

Class I (US FDA UDI)

by Tornier, Inc.

Identity

Trade Name: Aequalis Resurfacing Head FDA UDI
Generic Name: Orthopaedic implant calibration pin FDA UDI
Device Name: PIN - DO NOT IMPLANT FDA UDI
Model / Reference: DWD064 FDA UDI
Description: PIN - DO NOT IMPLANT FDA UDI

Identifiers

Catalog Number: DWD064 FDA UDI
Primary DI / UDI-DI: 03700386931802 FDA UDI
FDA Product Code: HWE FDA UDI
GMDN Term: Orthopaedic implant calibration pin FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.4820 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

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

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 — 3 Millimeter FDA UDI
Length — 170 Millimeter FDA UDI

Category: Orthopaedic implant calibration pin

Aequalis Resurfacing Head by Tornier, Inc. — Class I — 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 I	Pending data

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Manufacturer

Manufacturer: Tornier, Inc.

Sources (1)

FDA UDI a0f4caa4-b063-482e-ad83-68fcc3c72693 36 fields · synced Jun 1, 2026