FDA.reportPublic FDA data

H&H Combat Eye Sheild

Primary DI
00857048006217
Brand
H&H Combat Eye Sheild
Company
H&H MEDICAL CORPORATION
Model
1
Catalog number
HHCES01
Device description
H&H Combat Eye Shield, a sterile product with an aluminum eye shield surrounded by a circle of hydrogel to hold the shield in place without tape or adhesive.
Published
2020-12-31
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
00857048006217PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00857048006217008570480062178570480062170857048006217

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
804-642-3663info@gohandh.com

Regulatory Flags#

DUNS number
072656713
Device count
1
Premarket exempt
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00857048006064H&H Big Cinch Abdominal Bandage1BC012020-07-10
00857048006095H-Bandage Compression Dressing, Flat Fols1HBFF012020-07-10
00857048006101Thin H Compression Bandage, Standard Fold1HBT012020-07-10
00857048006118Thin H Compression Dressing, Flat Fold1HBTF2020-07-10
00857048006125Mini Compression Bandage1HHMCB012020-07-10
00857048006057H&H Situation Instrument Tray Kit1HHSIT012020-07-06
00857048006392SWAT-T Elastic Tourniquet, Black1SWAT-T-BLK-EA2020-12-31
00857048006422SWAT-T Elastic Tourniquet, Orange1SWAT-T-BLK-EA2020-12-31
00857048006316TK-4 Elastic Tourniquet1TK-42020-12-31
00857048006323TK-4L Elastic Tourniquet1TK-4L2020-12-31
00857048006484H&H Combat Medic Tape1CMRT012020-12-31
00857048006361H&H Compressed Gauze1HHPG2020-12-31
00857048006521H&H Flat Compressed Gauze1HHPF2020-12-31
00857048006538H&H TACgauze Wound Wrapping Gauze1TACG022020-12-31
00857048006545H&H MiniTAC Wound Wrapping Gauze1HHMTG012020-12-31
00857048006088H-Bandage Compression Dressing - Rolled1HB012020-07-10
00857048006583H&H Mini 2X Bandage/Gauze Combo Pack1HHM2X2021-03-17
00857048006590H&H Mini 2X Bandage/Gauze Combo Pack1HHM2X2021-03-17
00857048006132Bolin Chest Seal6BCS012020-12-31
00857048006552H&H 30fr Nasopharyngeal Airway, Each1.0HHNPA-EA2020-12-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10840113242426BovieASPEN SURGICAL PRODUCTS, INC.HOY2026-08-17
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