Dynamic Tissue Systems™ DCNE-01

GUDID 10620974001789

DynaCleft Nasal Elevation System

Southmedic Incorporated

Skin-closure adhesive strip Skin-closure adhesive strip Skin-closure adhesive strip Skin-closure adhesive strip Skin-closure adhesive strip Skin-closure adhesive strip Skin-closure adhesive strip Skin-closure adhesive strip Skin-closure adhesive strip Skin-closure adhesive strip Skin-closure adhesive strip Skin-closure adhesive strip Skin-closure adhesive strip Skin-closure adhesive strip

• Primary Device ID: 10620974001789
• NIH Device Record Key: c8a2ba8b-6024-4684-a4ca-bb0ef65abb0a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dynamic Tissue Systems™
• Version Model Number: DCNE-01
• Catalog Number: DCNE-01
• Company DUNS: 246848147
• Company Name: Southmedic Incorporated
• Device Count: 7
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• 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: +1(705)726-9383
• Email: custserv@southmedic.com
• Phone: +1(705)726-9383
• Email: custserv@southmedic.com
• Phone: +1(705)726-9383
• Email: custserv@southmedic.com
• Phone: +1(705)726-9383
• Email: custserv@southmedic.com
• Phone: +1(705)726-9383
• Email: custserv@southmedic.com
• Phone: +1(705)726-9383
• Email: custserv@southmedic.com
• Phone: +1(705)726-9383
• Email: custserv@southmedic.com
• Phone: +1(705)726-9383
• Email: custserv@southmedic.com
• Phone: +1(705)726-9383
• Email: custserv@southmedic.com
• Phone: +1(705)726-9383
• Email: custserv@southmedic.com
• Phone: +1(705)726-9383
• Email: custserv@southmedic.com
• Phone: +1(705)726-9383
• Email: custserv@southmedic.com
• Phone: +1(705)726-9383
• Email: custserv@southmedic.com
• Phone: +1(705)726-9383
• Email: custserv@southmedic.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00620974001782 [Primary]
GS1	10620974001789 [Package]; Contains: 00620974001782; Package: [1 Units]; In Commercial Distribution
GS1	20620974001786 [Unit of Use]

FDA Product Code

• MZR: TOPICAL APPROXIMATION SYSTEM

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: 2020-12-28
• Device Publish Date: 2020-12-18

On-Brand Devices [Dynamic Tissue Systems™]

• 10620974002342: ABRA Loop Cannulator
• 10620974002335: Cannulator
• 00620974002321: ABRA Button Tail
• 10620974002311: Elastomer Retainer
• 00620974002307: ABRA® Abdominal Wall Closure Set Extension
• 10620974001932: Southmedic Surgical Retainer Small
• 10620974001918: Southmedic Surgical Retainer Large
• 10620974001864: ABRA Silicone Cord Elastomer
• 10620974001796: DynaCleft Nasal Elevation System
• 10620974001789: DynaCleft Nasal Elevation System
• 10620974001772: DynaCleft Bilateral
• 10620974001765: DynaCleft Unilateral
• 10620974001758: DynaStretch Set
• 10620974001741: DynaStretch Set
• 10620974001734: DynaClose Set
• 10620974001727: DynaClose Set
• 10620974001710: SutureSafe Set
• 10620974001703: SutureSafe Set