FABCO

Basic Information

• Brand Name: FABCO
• Primary DI: 30634303800275
• Version / Model: Q604205
• Catalog Number: Q604205
• 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: 2016-11-01
• Public Version: 3
• Public Version Date: 2019-05-23
• Public Version Status: Update
• Public Device Record Key: 887625d7-3202-44c1-9b60-780d5706a7f5

Device Description

Corneal Light Shield

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: No
• 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
HOZ	Sponge, Ophthalmic	Ophthalmic	886.4790	2

GMDN Terms

Code	Name	Definition	Implantable	Status
37940	Retina illumination shield	A device typically made of a non-abrasive fluid-absorbing material (e.g., a sponge), intended to be placed on the surface of the cornea to shield the retina from excessive illumination during an ophthalmic procedure; it is not intended to protect the eye from exposure to harmful radiation. It is composed of material that resists the tearing or shredding of its fibres. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	50634303800279	GS1	Dispenser Box	20	In Commercial Distribution
Primary	30634303800275	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Height	1	Millimeter
Outer Diameter	7	Millimeter