FDA.report

Uniseal Unimask

Primary DI
30744514711304
Brand
Uniseal Unimask
Company
Uniseal
Model
711-3
Device description
Ear Loop Surgical Face Mask, Blue, Non-Sterile
Published
2022-08-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
FXXMask, Surgical

Product Code Classifications

CodeDeviceSpecialtyClass
FXXMask, SurgicalGeneral, Plastic Surgery2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
30744514711304PackageGS110In Commercial Distribution
20744514711307PrimaryGS10
10744514711300Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
3074451471130430744514711304
2074451471130720744514711307
1074451471130010744514711300

GMDN Terms

TermDefinition
Surgical/medical face mask, non-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 does not include an antimicrobial/antiviral agent(s) 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.

Sterilization Methods

Method

Regulatory Flags

DUNS number
782209340
Device count
50
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
30744514101501Uniseal High Risk Nitrile015X-02023-10-31
30744514101563Uniseal High Risk Nitrile015X-62023-10-31
30744514101570Uniseal High Risk Nitrile015X-72023-10-31
30744514101587Uniseal High Risk Nitrile015X-82023-10-31
30744514101594Uniseal High Risk Nitrile015X-92023-10-31
30744514142207Uniseal Bio-Nit Nitrile422A-02023-10-31
30744514142252Uniseal Bio-Nit Nitrile422A-52023-10-31
30744514142269Uniseal Bio-Nit Nitrile422A-62023-10-31
30744514142276Uniseal Bio-Nit Nitrile422A-72023-10-31
30744514142283Uniseal Bio-Nit Nitrile422A-82023-10-31
30744514142290Uniseal Bio-Nit Nitrile422A-92023-10-31
30744514015600Uniseal Nitrile Plus X-Tend156-02022-09-05
30744514015662Uniseal Nitrile Plus X-Tend156-62022-09-05
30744514015679Uniseal Nitrile Plus X-Tend156-72022-09-05
30744514015686Uniseal Nitrile Plus X-Tend156-82022-09-05
30744514015693Uniseal Nitrile Plus X-Tend156-92022-09-05
30744514077509Uniseal BlackSeal ST775-02022-08-29
30744514001054Uniseal ProDerma Smooth010-52022-08-22
30744514001061Uniseal ProDerma Smooth010-62022-08-22
30744514001078Uniseal ProDerma Smooth010-72022-08-22

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