FABCO

Basic Information

• Brand Name: FABCO
• Primary DI: 30634303800428
• Version / Model: Q605206
• Catalog Number: Q605206
• Company Name: FIRST AID BANDAGE CO INC
• Labeler DUNS: 001137280
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-03-05
• Public Version: 1
• Public Version Date: 2018-04-05
• Public Version Status: New
• Public Device Record Key: 9e98a29e-78fa-43ab-8bbd-2accdc388d31

Device Description

Fenestrated Ear Wick

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: 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
KCN	Ear Wick	Ear, Nose, Throat	874.5220	1

GMDN Terms

Code	Name	Definition	Implantable	Status
33468	Ear wick, non-biodegradable	A non-biodegradable packing material [e.g., loosely twisted unspun cotton, gauze, or polyvinyl alcohol (PVA)] intended to be used in the ear of a patient after internal ear surgery, and/or to administer medicinal substances to the ear to treat ear disorders. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	50634303800422	GS1	Dispenser Box	50	In Commercial Distribution
Primary	30634303800428	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Height	24	Millimeter
Outer Diameter	9	Millimeter