FDA.reportPublic FDA data

Health-Tec EarLoop Masks, Sensitive

Primary DI
D773450100011
Brand
Health-Tec EarLoop Masks, Sensitive
Company
Dental Health Products Inc
Model
450-10001
Catalog number
450-10001
Device description
Health-Tec EarLoop Masks, Sensitive, White
Published
2017-01-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FXXMask, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FXXMask, SurgicalGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D773450100013PackageHIBCC10In Commercial Distribution
D773450100015PackageHIBCC4In Commercial Distribution
D773450100011PrimaryHIBCC0
D773450100010Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Surgical/medical respirator, non-antimicrobial, single-useA form-shaped filtering mask designed to be placed over the nose and mouth of a healthcare worker to permit normal breathing while protecting the wearer and patient from large particles (e.g., body fluids, airborne particulate materials) and small particles (e.g., bacteria) during medical, surgical, dental, and isolation procedures; it does not include an antimicrobial agent(s). It is designed to create an airtight seal against the user’s face, and typically includes ties/head straps; it might incorporate a forming nosepiece (metal wire) and/or an exhalation valve. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
800-626-2163mhull@dhpi.net

Regulatory Flags#

DUNS number
623191194
Device count
50
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D773210HT40A121DHP Nanohybrid Composite210-HT40A12210-HT40A122022-10-20
D773210HT40A221DHP Nanohybrid Composite210-HT40A22210-HT40A222022-10-20
D773210HT40A321DHP Nanohybrid Composite210-HT40A32210-HT40A322022-10-20
D773210HT40A3521DHP Nanohybrid Composite210-HT40A352210-HT40A3522022-10-20
D773210HT40B121DHP Nanohybrid Composite210-HT40B12210-HT40B122022-10-20
D773210HT40B221DHP Nanohybrid Composite210-HT40B22210-HT40B222022-10-20
D773210HT40C221DHP Nanohybrid Composite210-HT40C22210-HT40C222022-10-20
D773210HT40C321DHP Nanohybrid Composite210-HT40C32210-HT40C322022-10-20
D773210HT50A120DHP Nanohybrid Composite210-HT50A12210-HT50A122022-10-20
D773210HT50A220DHP Nanohybrid Composite210-HT50A22210-HT50A222022-10-20
D773210HT50A320DHP Nanohybrid Composite210-HT50A32210-HT50A322022-10-20
D773210HT50A3520DHP Nanohybrid Composite210-HT50A352210-HT50A3522022-10-20
D773210HT50B120DHP Nanohybrid Composite210-HT50B12210-HT50B122022-10-20
D773210HT50C320DHP Nanohybrid Composite210-HT50C32210-HT50C322022-10-20
D773210HT10A121DHP Nanohybrid Flowable Composite210-HT10A12210-HT10A122022-10-19
D773210HT10A221DHP Nanohybrid Flowable Composite210-HT10A22210-HT10A222022-10-19
D773210HT10A321DHP Nanohybrid Flowable Composite210-HT10A32210-HT10A322022-10-19
D773210HT10A3521DHP Nanohybrid Flowable Composite210-HT10A352210-HT10A3522022-10-19
D773210HT10A421DHP Nanohybrid Flowable Composite210-HT10A42210-HT10A422022-10-19
D773210HT10B121DHP Nanohybrid Flowable Composite210-HT10B12210-HT10B122022-10-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809755250171KP Protective Face Mask KP trading Co., Ltd.FXX2026-02-19
10097604555514Tronex International, Inc.TRONEX INTERNATIONAL, INC.FXX2025-07-28
10371347011606Advance Dental ProductsThe Atlanta Dental Supply CompanyFXX2024-03-01
10371347011613Advance Dental ProductsThe Atlanta Dental Supply CompanyFXX2024-03-01
10371347011620Advance Dental ProductsThe Atlanta Dental Supply CompanyFXX2024-03-01
10097604543320Tronex International, Inc.TRONEX INTERNATIONAL, INC.FXX2024-01-19
10097604553022Tronex International, Inc.TRONEX INTERNATIONAL, INC.FXX2024-01-19
10097604563229Tronex International, Inc.TRONEX INTERNATIONAL, INC.FXX2024-01-19
10097604573624Tronex International, Inc.TRONEX INTERNATIONAL, INC.FXX2024-01-19
10195327560522Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FXX2023-12-21
10097604537022Tronex International, Inc.TRONEX INTERNATIONAL, INC.FXX2023-12-11
10097604538128Tronex International, Inc.TRONEX INTERNATIONAL, INC.FXX2023-12-11
10304040169022EssentialsHENRY SCHEIN, INC.FXX2023-07-05
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10304040168933CriterionHENRY SCHEIN, INC.FXX2023-06-26
10304040168940CriterionHENRY SCHEIN, INC.FXX2023-06-26
10087701434423Good NeighborShepard Medical Products, Inc.FXX2023-01-06
10096295122296LeaderShepard Medical Products, Inc.FXX2023-01-06
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