SPECWELL

Basic Information

• Brand Name: SPECWELL
• Primary DI: 04582697820117
• Version / Model: 8x 30
• Company Name: SPECWELL CORPORATION
• Labeler DUNS: 701065054
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-09-24
• Public Version: 2
• Public Version Date: 2022-11-09
• Public Version Status: Update
• Public Device Record Key: 79786299-6db6-47e9-a272-bc0d0253bb68

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: Yes
• Not Made with NRL: No
• MRI Safety: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• 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
HKB	Telescope, Hand-Held, Low-Vision	Ophthalmic	886.5870	1

GMDN Terms

Code	Name	Definition	Implantable	Status
46788	Indirect monocular ophthalmoscope, electrically-powered	An electrically-powered, hand-held, 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 one eye (monocular). 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 built-in light (e.g., non-polarized light) directed through the pupil to illuminate the interior of the eyeball, lenses, and filters.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04582697820117	GS1