DYNA-FLEX™

GUDID 15051978003427

Multi-Layer Compression System

SYSTAGENIX WOUND MANAGEMENT, LIMITED

Compression bandaging kit

• Primary Device ID: 15051978003427
• NIH Device Record Key: 12a68470-31a7-497a-828e-eb18194eb034
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DYNA-FLEX™
• Version Model Number: 7025
• Company DUNS: 211352227
• Company Name: SYSTAGENIX WOUND MANAGEMENT, LIMITED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• 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: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 866 978 3296
• Email: xx@xx.xx
• Phone: 866 978 3296
• Email: xx@xx.xx
• Phone: 866 978 3296
• Email: xx@xx.xx
• Phone: 866 978 3296
• Email: xx@xx.xx
• Phone: 866 978 3296
• Email: xx@xx.xx
• Phone: 866 978 3296
• Email: xx@xx.xx
• Phone: 866 978 3296
• Email: xx@xx.xx
• Phone: 866 978 3296
• Email: xx@xx.xx
• Phone: 866 978 3296
• Email: xx@xx.xx
• Phone: 866 978 3296
• Email: xx@xx.xx
• Phone: 866 978 3296
• Email: xx@xx.xx
• Phone: 866 978 3296
• Email: xx@xx.xx
• Phone: 866 978 3296
• Email: xx@xx.xx
• Phone: 866 978 3296
• Email: xx@xx.xx
• Phone: 866 978 3296
• Email: xx@xx.xx
• Phone: 866 978 3296
• Email: xx@xx.xx
• Phone: 866 978 3296
• Email: xx@xx.xx
• Phone: 866 978 3296
• Email: xx@xx.xx
• Phone: 866 978 3296
• Email: xx@xx.xx
• Phone: 866 978 3296
• Email: xx@xx.xx
• Phone: 866 978 3296
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	15051978003427 [Primary]
GS1	55051978003425 [Package]; Package: [8 Units]; In Commercial Distribution

FDA Product Code

• MCY: Wound Dressing Kit

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-10-25
• Device Publish Date: 2018-09-24

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• 25051978001109 - FIBRACOL® PLUS: 2020-05-06 Collagen Wound Dressing with Alginate
• 25051978001116 - FIBRACOL® PLUS: 2020-05-06 Collagen Wound Dressing with Alginate
• 25051978002830 - PROMOGRAN PRISMA®: 2020-01-10 Matrix
• 25051978002885 - PROMOGRAN PRISMA®: 2020-01-10 Matrix
• 25051978009990 - PROMOGRAN PRISMA®: 2020-01-10 Matrix