FDA.reportPublic FDA data

Unico High Performance Surgical Mask

Primary DI
08809783490594
Brand
Unico High Performance Surgical Mask
Company
UNICO GLOBAL INC
Model
SM-301T
Published
2022-03-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
true
Single use
true

Product Codes#

Code, Name table
CodeName
FXXMask, Surgical

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K210147000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K210147000Unico High Performance Surgical Mask, Unico High Performance Surgical Mask with Face ShieldUnicoglobal, Inc.2021-12-22FXX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809783490594PrimaryGS10
08809783490099Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809783490594088097834905948809783490594
08809783490099088097834900998809783490099

GMDN Terms#

Term, Definition table
TermDefinition
Surgical/medical respirator, antimicrobialA 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 and small particles during medical, surgical, dental, and isolation procedures; it includes an antimicrobial/antiviral agent to destroy specified pathogens under specified contact conditions. 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.

Regulatory Flags#

DUNS number
690513726
Device count
50
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08809783490426SURGICAL MASKSA-2001SM2022-03-18
08809783490587Unico High Performance Surgical MaskSM-301E2022-03-18
08809783490600Unico High Performance Surgical Mask With Face ShieldSM-301FS2022-03-18
08809783490617Unico High Performance Surgical Mask With Face ShieldSM-301FST2022-03-18
08809783490303DISPOSABLE NITRILE GLOVESA-2001NG2022-03-18
08809783490310FACE SHIELD MASKSA-2001FSM2022-03-18
08809783490327MEDICAL APRONSA-2001MA2022-03-18
08809783490402SURGICAL CAPSSA-2001CA2022-03-18
08809783490433SURGICAL MASK WITH FACE SHIELDSA-2001MFS2022-03-18
088097834906243PLY SURGICAL MASKFM-EU20012022-03-18
088097834906314PLY SURGICAL MASKFM-EU20022022-03-18
08809783490105Unico Global Level 3 Surgical Gown (Film-Reinforced SMS)SG-S2001S-S2022-03-18
08809783490112Unico Global Level 3 Surgical Gown (Film-Reinforced SMS)SG-S2001S-M2022-03-18
08809783490129Unico Global Level 3 Surgical Gown (Film-Reinforced SMS)SG-S2001S-L2022-03-18
08809783490136Unico Global Level 3 Surgical Gown (Film-Reinforced SMS)SG-S2001S-XL2022-03-18
08809783490143Unico Global Level 3 Surgical Gown (Film-Reinforced SMS)SG-S2001S-XXL2022-03-18
08809783490150Unico Global Level 3 Surgical Gown (Film-Reinforced SMS)SG-S2002NS-S2022-03-18
08809783490167Unico Global Level 3 Surgical Gown (Film-Reinforced SMS)SG-S2002NS-M2022-03-18
08809783490174Unico Global Level 3 Surgical Gown (Film-Reinforced SMS)SG-S2002NS-L2022-03-18
08809783490181Unico Global Level 3 Surgical Gown (Film-Reinforced SMS)SG-S2002NS-XL2022-03-18

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