FDA.reportPublic FDA data

Eye Shield

Primary DI
M68906205050
Brand
Eye Shield
Company
Safeguard US Operating, LLC
Model
05
Catalog number
06-205
Device description
"1ea - 2.375"" x 3"", polycarbonate eye shield w/garter3ea - 0.875"" x 2.625"" adhesive strips"
Published
2019-08-06
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

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
M68906205050PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Eye patchA device intended to be used to close/cover one or both eyes, for the purpose of protecting the eye after a procedure or as part of an ophthalmic therapeutic intervention. It is made of a synthetic or biological material. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
855-428-6074fulfillment@combatmedical.com

Regulatory Flags#

DUNS number
118492643
Device count
1
DM exempt
true
Premarket exempt
true
Kit
true
Lot or batch
true
Manufacturing date on label
true

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M68920510030Sentinel Chest Trauma Kit0320-5102018-09-13
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M68985205020Mojo Vehicle Rescue Bag - Advanced0285-2052026-07-22
M68985301040Mojo Vehicle Medical Bag - Basic0485-3012026-07-22
M68985303040Mojo Vehicle Medical Bag - Intermediate0485-3032026-07-22
M6898710003060Individual Trauma Kit - Advanced0687-100-032026-07-22
M6898730002040Medical Trauma Kit Shelter in Place (Intermediate)0487-300-022026-07-22
M6898730003050Medical Trauma Kit Shelter in Place (Advanced)0587-300-032026-07-22
M689HHCTUINK01030Chest Tube Insertion Kit03HHCTUINK012025-06-23
M689HHCTUINK0105030Chest Tube Insertion Kit Cast of 503HHCTUINK01-052025-06-23
M6898810502020Patrol Officer IFAK Intermediate0288-105-022018-09-20
M6898810503020Patrol Officer IFAK Advanced0288-105-032018-09-20
M6898810502030Patrol Officer IFAK Intermediate0388-105-022020-01-06
M6898810503030Patrol Officer IFAK Advanced0388-105-032020-01-06
M689PBEFAK010Point Blank Enterprises Employee FAK - Private Label01PBEFAK2026-07-09
M689SHSTARTPAXSM030SCHOOL TRAUMA ADVANCED RESPONSE KIT03SH-START-PAX-SM2026-06-22
M689SHSTARTSM030School Trauma Active Response Kit03SH-START-SM2026-06-22

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00827989008137SAFEVIEWHealth Care Logistics, Inc.HOY2026-07-10
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00840456222874JMUJMU DENTAL, INCHOY2026-07-07
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D125720CR4Premium PlusPremium Plus (Dongguan) LimitedHOY2026-06-09
D125720T4Premium PlusPremium Plus (Dongguan) LimitedHOY2026-06-09
D125720TR4Premium PlusPremium Plus (Dongguan) LimitedHOY2026-06-09
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
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