TopClosure

Basic Information

• Brand Name: TopClosure
• Primary DI: 07290108154108
• Version / Model: 3S-M Rescue Kit 8mm
• Catalog Number: 3SM-R-SBL8-GI
• Company Name: I.V.T. MEDICAL LTD
• Labeler DUNS: 514996339
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-11-13
• Public Version: 1
• Public Version Date: 2018-12-14
• Public Version Status: New
• Public Device Record Key: 8394ce04-8a34-443b-8fe2-fc6de390201d

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• 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: Yes
• 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
33873	Skin-closing tension device	A sterile device designed to apply continuous tension to an area of skin to stretch it to achieve a surplus of full thickness skin and subcutaneous tissue for the closure of a wound where the margins are too far apart for suturing, or prior to the surgical excision of a skin defect, or for the implantation of a prosthesis to provide additional skin for coverage; it may additionally be used for offloading sutures in closed wounds. It is typically available as automatic self-closing skin hooks, or a tension line inserted through skin hooks at the wound margins for constant or adjustable tension application. It may be used as an alternative to skin grafting. This is a single-use device.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07290108154108	GS1
Package	17290108154105	GS1	Blister Box	10	In Commercial Distribution
Package	27290108154102	GS1	Distribution Carton	10	In Commercial Distribution