3.6V PROFESSIONAL OPHTH IN CASE

GUDID 05055272719926

KEELER LIMITED

Direct ophthalmoscope, line-powered

• Primary Device ID: 05055272719926
• NIH Device Record Key: 0148bdbe-8e44-4612-a07d-e1a285f5b5f7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 3.6V PROFESSIONAL OPHTH IN CASE
• Version Model Number: 1128-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	05055272719926 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K893172

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

On-Brand Devices [3.6V PROFESSIONAL OPHTH IN CASE]

• 05055272700788: 1128-P-1014
• 05055272719926: 1128-P-1014-500