SLZ 3XP Di TBL USA

GUDID 05055272715287

KEELER LIMITED

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• Primary Device ID: 05055272715287
• NIH Device Record Key: 58ff2a8e-46fc-46c2-b32d-9cfc301a8102
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SLZ 3XP Di TBL USA
• Version Model Number: 3020-P-2028
• 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	05055272715287 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151394

FDA Product Code

• HJO: Biomicroscope, Slit-Lamp, 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: 2016-06-14

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