FDA.reportPublic FDA data

Medisca Safe-Sense

Primary DI
00338779579411
Brand
Medisca Safe-Sense
Company
Medisca Inc.
Model
5794-01
Catalog number
5794-01
Device description
Face Mask, Surgical (Non-Sterile), Medisca Safe-Sense
Published
2023-05-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

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
00338779579411PrimaryGS10
10338779579418Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00338779579411003387795794113387795794110338779579411
1033877957941810338779579418

GMDN Terms#

Term, Definition table
TermDefinition
Surgical/medical face mask, antimicrobial, single-useA flexible, loose-fitting mask designed to be placed over the mouth and/or nose of a healthcare worker to permit normal breathing while protecting the patient and wearer from the transfer of large particles (e.g., blood, body fluids, and airborne particulate materials). It includes an antimicrobial/antiviral agent to prevent/inhibit the proliferation of microbes under specified conditions and it is not a form-shaped filtering device (i.e., not a respirator). It is made of a flexible, porous fabric or paper material and is typically secured using elastic head straps or ties; it may incorporate a forming nosepiece (metal wire) and/or transparent face/eye visor. This is a single-use device.

Regulatory Flags#

DUNS number
794301960
Device count
50
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00338779597415Medisca Safe-Sense5974-015974-012023-05-12
00338779597514Medisca Safe-Sense5975-015975-012023-05-12
00338779597613Medisca Safe-Sense5976-015976-012023-05-12
00038779578314Medisca Safe-Sense5783-015783-012023-02-23
00338779597316Medisca Safe-Sense 5973-015973-012023-05-12
00338779553114MEDISCA TRANSFER PIPETTE5531-015531-012023-09-18
00338779998410Vaginal Suppository Applicator9984-019984-012023-09-10
00338779998427Vaginal Suppository Applicator9984-029984-022023-09-10
00338779998434Vaginal Suppository Applicator9984-039984-032023-09-10
10338779998417Vaginal Suppository Applicator9984-019984-012023-09-10
10338779998424Vaginal Suppository Applicator9984-029984-022023-09-10
10338779998431Vaginal Suppository Applicator9984-039984-032023-09-10
00038779733515PreciseDose Dispenser7335-017335-012023-03-15
00038779733522PreciseDose Dispenser7335-027335-022023-03-15
00338779559314MD Ophthalmic Dropper Bottles5593-015593-012023-05-15
00338779559321MD Ophthalmic Dropper Bottles5593-025593-022023-05-15
00338779565216Syringe with Tip Cap (For Oral/Topical Use)5652-015652-012023-05-15
00338779565223Syringe with Tip Cap (For Oral/Topical Use)5652-025652-022023-05-15
00338779565315Syringe with Tip Cap (For Oral/Topical Use)5653-015653-012023-05-15
00338779565322Syringe with Tip Cap (For Oral/Topical Use)5653-025653-022023-05-15

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
10304040169039EssentialsHENRY SCHEIN, INC.FXX2023-07-05
10304040169046CriterionHENRY SCHEIN, INC.FXX2023-07-05
10304040165253CriterionHENRY SCHEIN, INC.FXX2023-06-26
10304040165260CriterionHENRY SCHEIN, INC.FXX2023-06-26
10304040168483CriterionHENRY SCHEIN, INC.FXX2023-06-26
10304040168490CriterionHENRY SCHEIN, INC.FXX2023-06-26
10304040168582CriterionHENRY SCHEIN, INC.FXX2023-06-26
10304040168612CriterionHENRY SCHEIN, INC.FXX2023-06-26
10304040168629CriterionHENRY SCHEIN, INC.FXX2023-06-26
10304040168643CriterionHENRY SCHEIN, INC.FXX2023-06-26
10304040168650CriterionHENRY SCHEIN, INC.FXX2023-06-26
10304040168926CriterionHENRY SCHEIN, INC.FXX2023-06-26
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
10096295137382LeaderShepard Medical Products, Inc.FXX2023-01-06