VariTrax Single Band

GUDID 00850049938068

VariTrax Locking band with curved blunt needle

CircumFix Solutions, Inc.

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