FDA.reportPublic FDA data

Ishield

Primary DI
00840313200137
Brand
Ishield
Company
Noir Medical Technologies LLC
Model
Ishield
Published
2023-04-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HOYShield, eye, ophthalmic (including sunlamp protective eyewear and post-mydriatic eyewear)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HOYShield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)Ophthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840313200137PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840313200137008403132001378403132001370840313200137

GMDN Terms#

Term, Definition table
TermDefinition
Radiation/mechanical corneal shield, reusableA protective device intended to be placed on the cornea of a patient to protect the eyes from physical damage and/or exposure to primary and scattered radiation during a medical procedure [e.g., periorbital surgery, x-ray/CT scan, dermatological laser treatment]. It is typically in the form of a dome and is made of non-biodegradable, durable materials (e.g., lead, tungsten, glass, plastic) that provide mechanical protection and/or prevent the transmission of harmful radiation to the eyes. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
067354084
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840313205194UVShield, NoIR, GlareShield57_142023-03-23
00840313205217UVShield, NoIR, GlareShield57_162023-03-23
00840313205224UVShield, NoIR, GlareShield57_172023-03-23
00840313205316UVShield, NoIR, GlareShield57_182023-03-23
00840313205330UVShield, NoIR, GlareShield57_192023-03-23
00840313205705UVShield, NoIR, GlareShield57_202023-03-23
00840313205712UVShield, NoIR, GlareShield57_212023-03-23
00840313205750UVShield, NoIR, GlareShield57_222023-03-23
00840313205774UVShield, NoIR, GlareShield57_232023-03-23
00840313205781UVShield, NoIR, GlareShield57_242023-03-23
00840313205811UVShield, NoIR, GlareShield57_302023-03-23
00840313205910UVShield, NoIR, GlareShield57_312023-03-23
00840313206078UVShield, NoIR, GlareShield57_332023-03-23
00840313206283UVShield, NoIR, GlareShield57_33W2023-03-23
00840313206368UVShield, NoIR, GlareShield57_362023-03-23
00840313206399UVShield, NoIR, GlareShield57_36W2023-03-23
00840313206566UVShield, NoIR, GlareShield33_232023-03-23
00840313206573UVShield, NoIR, GlareShield33_242023-03-23
00840313206580UVShield, NoIR, GlareShield33_302023-03-23
00840313206597UVShield, NoIR, GlareShield33_312023-03-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00757770535583Bausch + LombBausch & Lomb IncorporatedHOY2026-04-30
16931918105420AllesetGRI Medical & Electronic Technology Co., Ltd.HOY2026-04-10
10620974004285BetterShieldSouthmedic IncorporatedHOY2025-12-19
D2481009320"""Heidi"" Protective Eyewear "HAGER WORLDWIDE, INC.HOY2025-10-22
D2481009330"""Ella"" Protective Eyewear "HAGER WORLDWIDE, INC.HOY2025-10-22
D2481009350"""Lucy"" Protective Eyewear "HAGER WORLDWIDE, INC.HOY2025-10-22
10827989003504Health Care Logistics, Inc®Health Care Logistics, Inc.HOY2025-01-08
TQ26126151971Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.HOY2024-12-09
10889483047910SunMed LLCSUNMED, LLCHOY2024-11-11
10887482176815BovieASPEN SURGICAL PRODUCTS, INC.HOY2024-08-26
00194613017101MSI Precision Specialty InstrumentsMed Saver, Inc.HOY2024-08-15
00194613028190MSI Precision Specialty InstrumentsMed Saver, Inc.HOY2024-08-15
00194613002770MSI Precision Specialty InstrumentsMed Saver, Inc.HOY2024-04-25
00630094055114Bioseal Inc.BIOSEALHOY2024-01-29
00630094055138Bioseal Inc.BIOSEALHOY2024-01-29
00630094055145Bioseal Inc.BIOSEALHOY2024-01-29
00630094055190Bioseal Inc.BIOSEALHOY2024-01-29
00630094404721Bioseal Inc.BIOSEALHOY2024-01-29
00630094540160Bioseal Inc.BIOSEALHOY2024-01-29
00630094540337Bioseal Inc.BIOSEALHOY2024-01-29
00630094540474Bioseal Inc.BIOSEALHOY2024-01-29
00630094551913Bioseal Inc.BIOSEALHOY2024-01-29
00630094551937Bioseal Inc.BIOSEALHOY2024-01-29
00630094053707Bioseal Inc.BIOSEALHOY2024-01-26
00630094053738Bioseal Inc.BIOSEALHOY2024-01-26
00630094053905Bioseal Inc.BIOSEALHOY2024-01-26
00630094540016Bioseal Inc.BIOSEALHOY2024-01-26
08052276029638Eye Shield AKTIVE SRLHOY2024-01-15
00630094183411Bioseal Inc.BIOSEALHOY2023-10-05
00630094183459Bioseal Inc.BIOSEALHOY2023-10-05