Level One

FDA UDI

Class I (US FDA UDI)

by KLS-Martin L.P.

Identity

Trade Name: LEVEL ONE FDA UDI
Generic Name: Sternal fixation device FDA UDI
Device Name: WAND, HOLDING, SCREW GUIDE, STERNAL, SP FDA UDI
Model / Reference: SP-2024-0001 FDA UDI
Description: WAND, HOLDING, SCREW GUIDE, STERNAL, SP FDA UDI

Identifiers

Primary DI / UDI-DI: 00888118146649 FDA UDI
FDA Product Code: FZX FDA UDI
GMDN Term: Sternal fixation device FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.4800 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

Yes

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

Category: Sternal fixation device

Level One by KLS-Martin L.P. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Sternal fixation device.

STERNALOCK® BLU SYSTEM — BIOMET MICROFIXATION, INC · Class II
Vanguard® — Biomet Orthopedics, Inc. · Class I
ARIX Sternal System Bone Screw — Jeil Medical Corporation · Class II
ARIX Sternal System Bone Plate — Jeil Medical Corporation · Class II
SternaFuse® Fixation System — FUSION INNOVATIONS · Class II
Valkyrie Thoracic Fixation System — J.M. Longyear Manufacturing, LLC · Class II
STERNALOCK® BLU SYSTEM — BIOMET MICROFIXATION, INC · Class II
Valkyrie Thoracic Fixation System — J.M. Longyear Manufacturing, LLC · Class II

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: KLS-Martin L.P.

Sources (1)

FDA UDI 5e670ce3-7513-4097-9694-ffe03fb59be5 35 fields · synced May 30, 2026