Nex-D2

FDA UDI

Class I (US FDA UDI)

by Next Orthosurgical

Identity

Trade Name: Nex-D2 FDA UDI
Generic Name: Spinal guidewire FDA UDI
Device Name: THREADED GUIDE WIRE, CENTER MARKING, 1.4MM X 500MM FDA UDI
Model / Reference: CBZB050-500 FDA UDI
Description: THREADED GUIDE WIRE, CENTER MARKING, 1.4MM X 500MM FDA UDI

Identifiers

Catalog Number: CBZB050-500 FDA UDI
Primary DI / UDI-DI: 00840314169211 FDA UDI
FDA Product Code: LXH FDA UDI
GMDN Term: Spinal guidewire FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 888.4540 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

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

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 — 1.4 Millimeter FDA UDI
Length — 500 Millimeter FDA UDI

Category: Spinal guidewire

Nex-D2 by Next Orthosurgical — 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: Next Orthosurgical

Sources (1)

FDA UDI 0505b7b3-6adf-431d-9fe8-c52a65b46f88 36 fields · synced May 30, 2026