3.6V STREAK RET & PROF OPHTH

Basic Information

• Brand Name: 3.6V STREAK RET & PROF OPHTH
• Primary DI: 05055272701686
• Version / Model: 1427-P-1059
• Company Name: KEELER LIMITED
• Labeler DUNS: 210164398
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-08-26
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 9c3943fc-cd9c-4161-8fbb-f3dc0d51d117

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: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• 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
HKL	Retinoscope, Ac-Powered	Ophthalmic	886.1780	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46784	Retinoscope, line-powered	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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05055272701686	GS1