FDA.reportPublic FDA data

Surgical Eye Shield

Primary DI
00854428006041
Brand
Surgical Eye Shield
Company
Jardon Eye Prosthetics, Inc.
Model
Small Orange
Published
2023-06-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

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
00854428006041PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00854428006041008544280060418544280060410854428006041

GMDN Terms#

Term, Definition table
TermDefinition
Surgical eye pressure shieldA non-sterile device intended to cover and mechanically protect the eyes of a patient during surgery to prevent potential ocular pressure hazards/injury associated with surgery (e.g., resulting from inadvertent pressure being applied to the eye by healthcare professionals, equipment, or due to the orientation of the patient). It is designed as a rigid external eye shield (e.g., goggle like) intended to adhere to the face. This is a single-use device.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Regulatory Flags#

DUNS number
118972350
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00854428006003Surgical Eye ShieldPediatric Orange2023-06-26
00854428006010Surgical Eye ShieldPediatric Green2023-06-26
00854428006027Surgical Eye ShieldPediatric White2023-06-26
00854428006034Surgical Eye ShieldPediatric Clear2023-06-26
00854428006058Surgical Eye ShieldSmall Green2023-06-26
00854428006065Surgical Eye ShieldSmall Clear2023-06-26
00854428006072Surgical Eye ShieldSmall Black2023-06-26
00854428006089Surgical Eye ShieldSmall White2023-06-26
00854428006096Surgical Eye ShieldMedium Orange2023-06-26
00854428006102Surgical Eye ShieldMedium Green2023-06-26
00854428006119Surgical Eye ShieldMedium Clear2023-06-26
00854428006126Surgical Eye ShieldMedium White2023-06-26
00854428006133Surgical Eye ShieldMedium Black2023-06-26
00854428006140Surgical Eye ShieldLarge Orange2023-06-26
00854428006157Surgical Eye ShieldLarge Green2023-06-26
00854428006164Surgical Eye ShieldLarge Clear2023-06-26
00854428006188Surgical Eye ShieldLarge White2023-06-26
00854428006195Lucite ConformerSmall2023-06-26
00854428006201Lucite ConformerMedium2023-06-26
00854428006218Lucite ConformerLarge2023-06-26

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
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08052276029638Eye Shield AKTIVE SRLHOY2024-01-15
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