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: 3MM X 250MM K-WIRE FDA UDI
Model / Reference: 313-35-00 FDA UDI
Description: 3MM X 250MM K-WIRE FDA UDI

Identifiers

Catalog Number: 313-35-00 FDA UDI
Primary DI / UDI-DI: 10885862247094 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

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

FDA UDI

Dimensions & Sizes

Size: Length — 250 Millimeter FDA UDI
Outer Diameter — 3 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 9dd91ad8-ec8f-4679-af11-8ed55c77436d 35 fields · synced May 30, 2026