VariTrax Single Band

GUDID 00850049938068

VariTrax Locking band with curved blunt needle

CircumFix Solutions, Inc.

Sternal fixation device Sternal fixation device Sternal fixation device Sternal fixation device Sternal fixation device Sternal fixation device Sternal fixation device Sternal fixation device Sternal fixation device Sternal fixation device Sternal fixation device Sternal fixation device Sternal fixation device Sternal fixation device Sternal fixation device Sternal fixation device Sternal fixation device

Primary Device ID	00850049938068
NIH Device Record Key	ca932214-726c-4a76-b4a9-690b76381502
Commercial Distribution Status	In Commercial Distribution
Brand Name	VariTrax Single Band
Version Model Number	CFSB-001S
Company DUNS	057130264
Company Name	CircumFix Solutions, Inc.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	MR Safe
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	true
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850049938068 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K232986

FDA Product Code

JDQ	Cerclage, Fixation

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2024-05-09
Device Publish Date	2024-05-01

Devices Manufactured by CircumFix Solutions, Inc.

00850049938006 - VariTrax Sternal CircumFixator Set	2024-05-09 VariTrax Sternal CircumFixator Set, 130mm
00850049938013 - VariTrax Sternal CircumFixator Set	2024-05-09 VariTrax Sternal CircumFixator Set, 142mm
00850049938020 - VariTrax Sternal CircumFixator Set	2024-05-09 VariTrax Sternal CircumFixator Set, 154mm
00850049938037 - VariTrax Sternal CircumFixator Set	2024-05-09 VariTrax Sternal CircumFixator Set, 166mm
00850049938044 - VariTrax Sternal CircumFixator Set	2024-05-09 VariTrax Sternal CircumFixator Set, 178mm
00850049938051 - VariTrax Sternal CircumFixator Set	2024-05-09 VariTrax Sternal CircumFixator Set, 186mm
00850049938068 - VariTrax Single Band	2024-05-09VariTrax Locking band with curved blunt needle
00850049938068 - VariTrax Single Band	2024-05-09 VariTrax Locking band with curved blunt needle
00850049938075 - VariTrax Sternal Template	2024-05-09 VariTrax Sternal Template