Firefly

Basic Information

• Brand Name: Firefly
• Primary DI: 00851289007088
• Version / Model: DE400
• Company Name: Firefly Global
• Labeler DUNS: 020089936
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-09-10
• Public Version: 1
• Public Version Date: 2018-10-11
• Public Version Status: New
• Public Device Record Key: 336a9faf-cab0-44fc-9657-a713aef21e8d

Device Description

Digital Iris Scope

Device Characteristics

• Single Use: No
• 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: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HRB	Microscope, Operating, Non-Electric, Ophthalmic	General, Plastic Surgery	878.4700	1

GMDN Terms

Code	Name	Definition	Implantable	Status
58860	Multi-purpose digital medical camera lens, extraocular	A non-sterile optical device intended for attachment to a multi-purpose digital medical camera to provide high-resolution focusing of digital imaging data from the surface of the eye and adjacent areas. It may use white and/or blue light for the capture of specialized images (e.g., dry eye). This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00851289007088	GS1