STERN FIX

GUDID 28437006085445

STERN FIX Sternal Stabilization System, Size 1

NEOS SURGERY SL

Sternal fixation device

• Primary Device ID: 28437006085445
• NIH Device Record Key: acfb5f09-854a-44d0-b0d7-cba2dea3438f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: STERN FIX
• Version Model Number: SC010111
• Company DUNS: 465890437
• Company Name: NEOS SURGERY SL
• 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: false
• 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

Customer Support Contacts

• Phone: +34935944726
• Email: info@neosurgery.com
• Phone: +34935944726
• Email: info@neosurgery.com
• Phone: +34935944726
• Email: info@neosurgery.com
• Phone: +34935944726
• Email: info@neosurgery.com
• Phone: +34935944726
• Email: info@neosurgery.com
• Phone: +34935944726
• Email: info@neosurgery.com
• Phone: +34935944726
• Email: info@neosurgery.com
• Phone: +34935944726
• Email: info@neosurgery.com
• Phone: +34935944726
• Email: info@neosurgery.com
• Phone: +34935944726
• Email: info@neosurgery.com
• Phone: +34935944726
• Email: info@neosurgery.com
• Phone: +34935944726
• Email: info@neosurgery.com
• Phone: +34935944726
• Email: info@neosurgery.com
• Phone: +34935944726
• Email: info@neosurgery.com
• Phone: +34935944726
• Email: info@neosurgery.com
• Phone: +34935944726
• Email: info@neosurgery.com
• Phone: +34935944726
• Email: info@neosurgery.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	08437006085441 [Primary]
GS1	28437006085445 [Package]; Contains: 08437006085441; Package: [64 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K221795

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: 2024-09-09
• Device Publish Date: 2024-09-01

On-Brand Devices [STERN FIX]

• 28437006085445: STERN FIX Sternal Stabilization System, Size 1
• 28437006085483: STERN FIX Sternal Stabilization System- Size 5
• 08437006085472: STERN FIX Sternal Stabilization System-Size 4
• 28437006085469: STERN FIX Sternal Stabilization System- size 3
• 28437006085452: STERN FIX Sternal Stabilization System, Size 2