FDA.reportPublic FDA data

Clear Eye Shield

Primary DI
00813465012163
Brand
Clear Eye Shield
Company
HURRICANE MEDICAL INC
Model
9402
Catalog number
9402
Device description
Protects the eye during or after surgery, or after trauma. Universal for left or right eye.
Published
2020-05-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
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
00813465012163PrimaryGS10
10813465012160Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00813465012163008134650121638134650121630813465012163
1081346501216010813465012160

GMDN Terms#

Term, Definition table
TermDefinition
Eye maskA mechanical shield intended to be fitted over the eyes to prevent the intrusion of light, typically to facilitate rest or sleep in illuminated environments and/or at home. It typically consists of an external covering made of an opaque plastic, or other appropriate material, that does not allow the passage of light and that is lined with a padded inner liner (e.g., foam, gauze); it is held in place with a strap(s). It is intended for single-patient use.

Sterilization Methods#

Method table
Method
"[""Radiation Sterilization"", ""Ethylene Oxide""]"

Regulatory Flags#

DUNS number
093377724
Device count
50
DM exempt
true
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00813465012071Surgical Glide920192012020-05-05
00813465012101IOL Glide - Sheets920492042020-05-05
00813465011135IOL Manipulator - Lester680168012020-05-08
00813465011142IOL Manipulator - Sinskey680268022020-05-08
00813465011166IOL Manipulator - Sinskey680468042020-05-08
00813465011173Nucleus Chopper - P. Koch681068102020-05-08
00813465011180Nucleus Chopper - Beckingsale681168112020-05-08
10813465011132IOL Manipulator - Lester680168012020-05-08
10813465011149IOL Manipulator - Sinskey680268022020-05-08
10813465011163IOL Manipulator - Sinskey680468042020-05-08
10813465011170Nucleus Chopper - P. Koch681068102020-05-08
10813465011187Nucleus Chopper - Beckingsale681168112020-05-08
00813465011197Silicone Tubing700270022020-05-07
00813465011319Marker Pad - Gentian Violet730373032020-05-07
00813465011326Marker Pad - Methylene Blue730473042020-05-07
00813465011432Dual Tip Marker Pen - Gentian Violet731973192020-05-07
00813465011449Dual Tip Marker Pen - Methylene Blue732073202020-05-07
00813465012125.20 Micron Filter930193012020-05-07
00813465012149Male to Male Luer Connector930393032020-05-07
10813465011194Silicone Tubing700270022020-05-07

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
00630094183411Bioseal Inc.BIOSEALHOY2023-10-05
00630094183459Bioseal Inc.BIOSEALHOY2023-10-05