3.6V PROFESSIONAL STREAK LED RETINOSCOPE IN CASE

GUDID 05055272719957

KEELER LIMITED

Retinoscope, line-powered

• Primary Device ID: 05055272719957
• NIH Device Record Key: ad940cfd-6df5-4edf-b095-22108c948a6d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 3.6V PROFESSIONAL STREAK LED RETINOSCOPE IN CASE
• Version Model Number: 1302-P-1014-500
• Company DUNS: 210164398
• Company Name: KEELER LIMITED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	05055272719957 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K893171

FDA Product Code

• HKL: Retinoscope, Ac-Powered

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-03-06
• Device Publish Date: 2020-02-27

Devices Manufactured by KEELER LIMITED

• 05055272719674 - 532nm LIO: 2021-07-28
• 05055272720328 - 514/810nm LIO: 2021-07-28
• 05055272720380 - 577nm LIO: 2021-07-28
• 05055272719926 - 3.6V PROFESSIONAL OPHTH IN CASE: 2020-03-06
• 05055272719933 - 3.6V SPECIALIST OPHTH IN CASE: 2020-03-06
• 05055272719940 - 3.6V PROFESSIONAL STREAK RETINOSCOPE IN CASE: 2020-03-06
• 05055272719957 - 3.6V PROFESSIONAL STREAK LED RETINOSCOPE IN CASE: 2020-03-06
• 05055272719957 - 3.6V PROFESSIONAL STREAK LED RETINOSCOPE IN CASE: 2020-03-06
• 05055272719964 - US PROFESSIONAL LED STUDENT KIT-SLIM: 2020-03-06