CORNEAL SHIELD H75A

GUDID 00841494102395

CORNEAL SHIELD S(RED),4 SHIELDS,1 HANDLE

Ellman International

Epithelial-resurfacing corneal shield

• Primary Device ID: 00841494102395
• NIH Device Record Key: ddd23262-54a6-42b2-aace-fe67785c8e11
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CORNEAL SHIELD
• Version Model Number: H75A
• Catalog Number: H75A
• Company DUNS: 079095245
• Company Name: Ellman International
• Device Count: 4
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841494102395 [Primary]
GS1	00841494105785 [Unit of Use]

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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-05-23
• Device Publish Date: 2016-09-21

On-Brand Devices [CORNEAL SHIELD]

• 00841494102395: CORNEAL SHIELD S(RED),4 SHIELDS,1 HANDLE
• 00841494102388: CORNEAL SHIELD M(GREEN),4 SHIELD,1 HDLE
• 00841494102371: CORNEAL SHIELD L(BLUE), 4 SHIELD, 1 HDLE