Dynamic Tissue Systems™

Basic Information

• Brand Name: Dynamic Tissue Systems™
• Primary DI: 00620974001768
• Version / Model: DCX10
• Catalog Number: DCX10
• Company Name: Southmedic Incorporated
• Labeler DUNS: 246848147
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 7
• Record Status: Published
• Publish Date: 2020-12-18
• Public Version: 1
• Public Version Date: 2020-12-28
• Public Version Status: New
• Public Device Record Key: 2b4c6379-2fad-48e9-8f67-49c9cba80828

Device Description

DynaCleft Unilateral

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MKY	SYSTEM, SKIN CLOSURE	General, Plastic Surgery	878.4320	1

GMDN Terms

Code	Name	Definition	Implantable	Status
32207	Skin-closure adhesive strip	A small, narrow flexible band (of fabric, plastic, paper, or other material) coated on one side with a pressure-sensitive adhesive, used to approximate the edges of superficial wounds. The device may be hypoallergenic and/or waterproof. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10620974001765	GS1		1	In Commercial Distribution
Primary	00620974001768	GS1
Unit of Use	20620974001762	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]