Keeler Kapture Lite to View Std Upgrade

GUDID 05055272718028

KEELER LIMITED

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• Primary Device ID: 05055272718028
• NIH Device Record Key: 83c84ca6-d181-478b-be96-718b2c2a1a68
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Keeler Kapture Lite to View Std Upgrade
• Version Model Number: 3020-P-7045
• 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: false
• Serial Number: true
• 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	05055272718028 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140450

FDA Product Code

• HKI: Camera, Ophthalmic, 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

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