Sharn Inc S2020-P

GUDID 00811571030880

EyeGard Pediatric

CLEAR IMAGE DEVICES LLC

Eye patch

• Primary Device ID: 00811571030880
• NIH Device Record Key: afc4ad71-38e6-41b1-a2ea-e70ed5c3af50
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sharn Inc
• Version Model Number: S2020P
• Catalog Number: S2020-P
• 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	00811571030880 [Primary]
GS1	00817518022161 [Previous]

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