3.6V SPECIALIST OPHTH IN CASE

GUDID 05055272700900

KEELER LIMITED

Direct ophthalmoscope, line-powered

• Primary Device ID: 05055272700900
• NIH Device Record Key: 5fc97f6f-2571-4d62-bbae-8e22ce2374cf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 3.6V SPECIALIST OPHTH IN CASE
• Version Model Number: 1132-P-1157
• 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	05055272700900 [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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-08-26

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

• 05055272700900: 1132-P-1157
• 05055272719933: 1132-P-1157-500