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Equinoxe®

FDA UDI

Class I (US FDA UDI)

by Exactech, Inc.

Identity

Trade Name
Equinoxe® FDA UDI
Generic Name
Reverse shoulder cup prosthesis trial, reusable FDA UDI
Device Name
Humeral Liner Trial, Constrained FDA UDI
Model / Reference
325-46-10 FDA UDI
Description
Humeral Liner Trial, Constrained FDA UDI

Identifiers

Catalog Number
325-46-10 FDA UDI
Primary DI / UDI-DI
10885862624994 FDA UDI
FDA Product Code
HWT FDA UDI
GMDN Term
Reverse shoulder cup prosthesis trial, reusable FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
888.4800 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size
Angle — 135 degree FDA UDI

Category: Reverse shoulder cup prosthesis trial, reusable

Equinoxe® by Exactech, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Reverse shoulder cup prosthesis trial, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Exactech, Inc.

Sources (1)

  • FDA UDI e794fe66-348a-4082-adba-ad1e4a17bfdd 35 fields · synced Jun 8, 2026