Sharn Inc 42593

GUDID 00811571030842

EyeGuardian Sensitive

CLEAR IMAGE DEVICES LLC

Eye patch

• Primary Device ID: 00811571030842
• NIH Device Record Key: a8ada8f0-95c2-4542-9873-3ff69fd23ab0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sharn Inc
• Version Model Number: 42593
• Catalog Number: 42593
• Company DUNS: 115272845
• Company Name: CLEAR IMAGE DEVICES LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00811571030842 [Primary]

FDA Product Code

• HOY: Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)

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: 2021-08-30
• Device Publish Date: 2021-08-20

On-Brand Devices [Sharn Inc]

• 00811571030880: EyeGard Pediatric
• 00811571030873: EyeGard Sensitive
• 00811571030866: EyeGard
• 00811571030859: EyeGuardian
• 00811571030842: EyeGuardian Sensitive