VariTrax Sternal Template

FDA UDI

Class I (US FDA UDI)

by Circumfix Solutions, Inc

Identity

Trade Name: VariTrax Sternal Template FDA UDI
Generic Name: Sternal fixation device FDA UDI
Device Name: VariTrax Sternal Template FDA UDI
Model / Reference: CFTK-TEMP FDA UDI
Description: VariTrax Sternal Template FDA UDI

Identifiers

Primary DI / UDI-DI: 00850049938075 FDA UDI
FDA Product Code: HWT FDA UDI
GMDN Term: Sternal fixation device 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

Yes

FDA UDI

Single Use

Yes

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

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Safe FDA UDI

Category: Sternal fixation device

VariTrax Sternal Template by Circumfix Solutions, Inc — 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: Circumfix Solutions, Inc

Sources (1)

FDA UDI 02acadfd-2a66-4552-93b9-1bf530ed9c49 33 fields · synced Jun 1, 2026