SIGMA 250 M2

Basic Information

• Brand Name: SIGMA 250 M2
• Primary DI: 04053755180721
• Version / Model: 000
• Catalog Number: C-008.33.330
• Company Name: Heine Optotechnik GmbH & Co. KG
• Labeler DUNS: 315274563
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-12-12
• Public Version: 1
• Public Version Date: 2022-12-20
• Public Version Status: New
• Public Device Record Key: afb4e30b-36fd-4b6b-9952-4c23eddbefe6

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: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• 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
HLJ	Ophthalmoscope, Battery-Powered	Ophthalmic	886.1570	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46790	Indirect binocular ophthalmoscope	An electrically-powered, head-worn, ophthalmic instrument designed to be held arm’s length from the patient to examine the interior of the eye and related structures [e.g., fundus (retina), cornea, aqueous, lens, vitreous] using the examiner’s two eyes simultaneously (stereoscopic vision). It is intended to provide a wide field of view and produce an inverted (reversed) image of approximately 2 to 5 times magnification. It typically consists of a main light to illuminate the interior of the eyeball, lenses, filters and an illuminator beam to eliminate reflexes; it can be mounted on a headband or spectacle frames.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04053755180721	GS1

Customer Contacts

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