3.6V PROFESSIONAL OPHTH IN CASE

GUDID 05055272700788

KEELER LIMITED

Direct ophthalmoscope, line-powered

• Primary Device ID: 05055272700788
• NIH Device Record Key: 685ff4c2-905e-49a3-91a0-5b2f12231c4b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 3.6V PROFESSIONAL OPHTH IN CASE
• Version Model Number: 1128-P-1014
• 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	05055272700788 [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 PROFESSIONAL OPHTH IN CASE]

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