Device
SR24B
Manufacturer
Zumax Medical Co., LTD
Model: SR24B Catalog: 418E6812 DI: 06945095544531 Status: New MRI: Labeling does not contain MRI Safety Information Single-use: No Rx: No OTC: No
First Published: 2026-05-21 Current Version: 2026-05-29
Sterilization
Device Sterile: No
Sterilization Prior To Use: No
Regulatory & Distribution
Record Status: Published
Version Number: 1
Record Key: d63cb0cc-9b4d-4b0e-a709-33e618514910
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: 06945095544531
Type: Primary
Issuing Agency: GS1
GMDN
Code: 32712
Name: Retinoscope, battery-powered
Definition:
A battery-powered, hand-held, ophthalmic instrument 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 batteries may be of the rechargeable type, and are housed within the handle of the instrument. Also known as a skiascope and the method as sciascopy.
FDA Product Codes
HKM
Retinoscope, Battery-Powered