ENDURE INDUSTRIES

Basic Information

• Brand Name: ENDURE INDUSTRIES
• Primary DI: 00840118611459
• Version / Model: EKR24A3
• Catalog Number: EKR24A3
• Company Name: ENDURE INDUSTRIES
• Labeler DUNS: 066087031
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-10-15
• Public Version: 1
• Public Version Date: 2023-10-23
• Public Version Status: New
• Public Device Record Key: 22f1ee71-a8d6-4b70-ba60-9eb5c353b1ea

Device Description

Endure Skin Closures, Reinforced, 1/2" x 4" (10 strips/sheet, 2 sheet/pouch)

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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: No
• 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	00840118611466	GS1	Box	50	In Commercial Distribution
Primary	00840118611459	GS1

Customer Contacts

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

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: 0 – 49 Degrees Celsius
• Type: Storage Environment Temperature
• Temperature Range: 0 – Degrees Celsius