First Aid Only

Basic Information

• Brand Name: First Aid Only
• Primary DI: 00092265050104
• Version / Model: FAE-5010
• Catalog Number: FAE-5010
• Company Name: Acme United Corporation
• Labeler DUNS: 001180207
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-08-10
• Public Version: 1
• Public Version Date: 2021-08-18
• Public Version Status: New
• Public Device Record Key: 974e14fe-d138-492d-bb18-d06f712f00a6

Device Description

Smart Compliance Butterfly Wound closures refill - 10/box

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: 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: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KGX	Tape And Bandage, Adhesive	General Hospital	880.5240	1

GMDN Terms

Code	Name	Definition	Implantable	Status
34865	Butterfly skin-closure adhesive strip	A small, narrow piece of flexible material covered on one side with a pressure-sensitive adhesive, and with broad, wing-shaped ends that function to approximate the edges of a superficial wound. 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
Primary	00092265050104	GS1

Customer Contacts

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