Device
SR24F
Manufacturer
Zumax Medical Co., LTD
Model: SR24F Catalog: 418-2002 DI: 06945095544333 Status: New MRI: Labeling does not contain MRI Safety Information Single-use: No Rx: No OTC: No
First Published: 2026-05-20 Current Version: 2026-05-28
Sterilization
Device Sterile: No
Sterilization Prior To Use: No
Regulatory & Distribution
Record Status: Published
Version Number: 1
Record Key: 6b30838f-22a1-458a-8e2a-3201bc2f7350
Distribution Status: In Commercial Distribution
DUNS Number: 421348837
Device Count: 1
DM Exempt: No
Premarket Exempt: Yes
HCT/P: No
Kit: No
Combination Product: No
Lot/Batch Tracked: Yes
Serial Number Tracked: No
Manufacturing Date Tracked: Yes
Expiration Date Tracked: No
Donation ID Number Tracked: No
Labeled Contains NRL: No
Labeled No NRL: No
Identifiers
Device ID: 06945095544333
Type: Primary
Issuing Agency: GS1
GMDN
Code: 46784
Name: Retinoscope, line-powered
Definition:
A mains electricity (AC-powered), hand-held, ophthalmic device that is used to measure the refractive errors of the eye through the projection of a beam of light into the eye, and the observation of the movement of the illuminated area on the retinal surface and of the refraction of the emergent rays. The current power is run through a transformer for reduction to low-voltage. Also known as a skiascope and the method as sciascopy.
FDA Product Codes
HKL
Retinoscope, Ac-Powered