VariTrax Sternal CircumFixator Set

GUDID 00850049938020

VariTrax Sternal CircumFixator Set, 154mm

CircumFix Solutions, Inc.

Sternal fixation device

• Primary Device ID: 00850049938020
• NIH Device Record Key: f5e588ca-23e9-4896-a3a2-6f6e1e328030
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VariTrax Sternal CircumFixator Set
• Version Model Number: CFSK-0154
• 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	00850049938020 [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