VariTrax Sternal CircumFixator Set

GUDID 00850049938006

VariTrax Sternal CircumFixator Set, 130mm

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	00850049938006
NIH Device Record Key	6ac0153e-c3e2-4ba8-89cd-cc380c2d6d3a
Commercial Distribution Status	In Commercial Distribution
Brand Name	VariTrax Sternal CircumFixator Set
Version Model Number	CFSK-0130
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	00850049938006 [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

On-Brand Devices [VariTrax Sternal CircumFixator Set]

00850049938051	VariTrax Sternal CircumFixator Set, 186mm
00850049938044	VariTrax Sternal CircumFixator Set, 178mm
00850049938037	VariTrax Sternal CircumFixator Set, 166mm
00850049938020	VariTrax Sternal CircumFixator Set, 154mm
00850049938013	VariTrax Sternal CircumFixator Set, 142mm
00850049938006	VariTrax Sternal CircumFixator Set, 130mm