3.6V SPECIALIST OPHTH IN CASE

GUDID 05055272719933

KEELER LIMITED

Direct ophthalmoscope, line-powered

• Primary Device ID: 05055272719933
• NIH Device Record Key: 5e6b6c3a-9c88-4eb9-a2a4-21b87be20c12
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 3.6V SPECIALIST OPHTH IN CASE
• Version Model Number: 1132-P-1157-500
• 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	05055272719933 [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 SPECIALIST OPHTH IN CASE]

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