Ishield

GUDID 00840313200137

Noir Medical Technologies LLC

Radiation/mechanical corneal shield, reusable

• Primary Device ID: 00840313200137
• NIH Device Record Key: 45762b36-d81a-4f42-856b-57dc4c714ba4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ishield
• Version Model Number: Ishield
• Company DUNS: 067354084
• Company Name: Noir Medical Technologies 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: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• 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	00840313200137 [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: 2023-04-11
• Device Publish Date: 2023-04-03

Devices Manufactured by Noir Medical Technologies LLC

• 00840313200137 - Ishield: 2023-04-11
• 00840313200137 - Ishield: 2023-04-11
• 00840313205194 - UVShield, NoIR, GlareShield: 2023-03-31
• 00840313205217 - UVShield, NoIR, GlareShield: 2023-03-31
• 00840313205224 - UVShield, NoIR, GlareShield: 2023-03-31
• 00840313205316 - UVShield, NoIR, GlareShield: 2023-03-31
• 00840313205330 - UVShield, NoIR, GlareShield: 2023-03-31
• 00840313205705 - UVShield, NoIR, GlareShield: 2023-03-31
• 00840313205712 - UVShield, NoIR, GlareShield: 2023-03-31