FDA.reportPublic FDA data

Plak Smacker

Primary DI
00843471100097
Brand
Plak Smacker
Company
YOUNG INNOVATIONS HOLDINGS LLC
Model
100114
Catalog number
100114
Device description
Trufit Blue Facemask (50/bx)
Published
2018-02-13
Public version status
Update
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
00843471100097PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00843471100097008434711000978434711000970843471100097

GMDN Terms#

Term, Definition table
TermDefinition
Surgical/medical face mask, 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) during medical procedures and patient examination; 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 intended to protect the upper face/eyes from debris/fluid. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
078739060
Device count
1
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00843471100004OrthoStore - BUBBLEGUM 625-100 625-100 2018-02-19
00843471100011OrthoStore - COTTON CANDY 625-125625-1252018-02-19
00843471100028OrthoStore - STRAWBERRY 625-200625-2002018-02-19
00843471100035OrthoStore - MINT 625-300625-3002018-02-19
00843471100042OrthoStore - GRAPE625-400625-4002018-02-19
00843471100059OrthoStore - ROOTBEER 625-450625-4502018-02-19
00843471100066OrthoStore - CHERRY 625-500625-5002018-02-19
00843471100073OrthoStore - WATERMELON625-650625-6502018-02-19
00843471100080OrthoStore- PINA-COLADA 625-700625-7002018-02-19
00843471100103OrthoStore - REPLICA, NO FLAVOR ALGINATE625-963625-9632018-02-23
00843471100110OrthoStore - KROMATICA ALGINATE, No Flavor625-964625-9642018-02-23
00843471100127OrthoStore - REPLICA, MINT FLAVOR ALGINATE625-973625-9732018-02-23
00843471100134OrthoStore - KROMATICA ALGINATE, MINT625-974625-9742018-02-23

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