FDA.reportPublic FDA data

Combat Eye Shield

Primary DI
M689HHCES01040
Brand
Combat Eye Shield
Company
Safeguard US Operating, LLC
Model
04
Catalog number
HHCES01
Device description
1EA - STERILE HYDROGEL DRESSING W / RIGID EYE SHIELD; 2EA- STERILE GAUZE
Published
2022-09-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Sterile
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
M689HHCES01040PrimaryHIBCC0

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

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
M68988441050Mojo Multi Mission Bag - Basic0584-4412019-10-31
M689GOIO040GO IO Intraosseous Start Kit 12/Case04GO IO2024-12-12
M68980100150INTRAVENOUS INFUSION STARTER SET1580-1002026-05-04
M6898010020040INTRAVENOUS INFUSION STARTER SET Case of 200480-100-202026-05-04
M68980801D160Fresh Whole Blood Donor Transfusion Set1680-801-D2026-05-04
M68980801R120Fresh Whole Blood Recipient Set1280-801-R2026-05-04
M6898250403050MEDIC ENHANCEMENT SET0582-504-032026-06-03
M689801101006080-110-10 Saline Lock Kit Case of 100680-110-102026-05-29
M68980110150SALINE LOCK KIT1580-1102026-05-29
M6898143003020Maritime Boat Box - Advanced0281-430-032026-05-28
M6898444601190Mojo Multi Mission - Advanced1984-446-012026-05-27
M689HHCTUINK01050Chest Tube Insertion Kit05HHCTUINK012026-05-27
M689HHCTUINK0105050Chest Tube Insertion Kit Cast of 505HHCTUINK01-052026-05-27
M689801101005080-110-10 Saline Lock Kit Case of 100580-110-102025-04-16
M68980110140SALINE LOCK KIT1480-1102025-01-11
M6898143003010Maritime Boat Box - Advanced0181-430-032025-07-11
M689HHCTUINK01040Chest Tube Insertion Kit04HHCTUINK012025-12-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00827989008137SAFEVIEWHealth Care Logistics, Inc.HOY2026-07-10
00860009651647KC Eye Tape - 50 PairsKelCor, LLCHOY2026-07-10
00840456222867JMUJMU DENTAL, INCHOY2026-07-07
00840456222874JMUJMU DENTAL, INCHOY2026-07-07
D125720C4Premium PlusPremium Plus (Dongguan) LimitedHOY2026-06-09
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
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