Equinoxe

FDA UDI

Class I (US FDA UDI)

by Exactech, Inc.

Identity

Trade Name: Equinoxe FDA UDI
Generic Name: Intraoperative bone pin/screw, non-sterile FDA UDI
Device Name: K-WIRE, 1.6mm x 150mm FDA UDI
Model / Reference: 341-35-00 FDA UDI
Description: K-WIRE, 1.6mm x 150mm FDA UDI

Identifiers

Catalog Number: 341-35-00 FDA UDI
Primary DI / UDI-DI: 10885862089052 FDA UDI
FDA Product Code: HWE FDA UDI
GMDN Term: Intraoperative bone pin/screw, non-sterile 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

FDA UDI

Single Use

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

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size: Outer Diameter — 1.6 Millimeter FDA UDI
Length — 150 Millimeter FDA UDI

Category: Intraoperative bone pin/screw, non-sterile

Equinoxe by Exactech, 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: Exactech, Inc.

Sources (1)

FDA UDI aff89eb8-059f-489f-80bc-d01cb3331c1c 35 fields · synced Jun 8, 2026