FDA.reportPublic FDA data

MIRABRUSH BLUE STRAIGHT

Primary DI
D2486054311
Brand
MIRABRUSH BLUE STRAIGHT
Company
HAGER WORLDWIDE, INC.
Model
605431
Device description
Dental applicator brush
Published
2023-08-04
Public version status
New
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
KFXASSEMBLY, THIGH/KNEE/SHANK/ANKLE/FOOT, EXTERNAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KFXAssembly, Thigh/Knee/Shank/Ankle/Foot, ExternalPhysical Medicine2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D2486054311PrimaryHIBCC0
D2486054310Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental material application tool, single-useA hand-held manual dental instrument intended to be used for the application of a dental restorative material (e.g., amalgam, resin) to a patient’s tooth/teeth; the restorative material is not included. It includes a handle with an application tip/brush which holds the material on its surface/bristles; it is not a syringe- or pistol-like device. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
+1(828)624-3319d.pritchard@hagerworldwide.com

Regulatory Flags#

DUNS number
009277971
Device count
100
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D2486058711Hager Prophy Brush Regular Flat6058712026-05-12
D2486058701Hager Prophy Brush Fine Flat6058702026-05-12
D248938521Uni-Wedge Regular ( Orange)938522026-01-28
D248938520Uni-Wedge Regular ( Orange)938522026-01-28
D2481009320"""Heidi"" Protective Eyewear "1009322025-10-22
D2481009330"""Ella"" Protective Eyewear "1009332025-10-22
D2481009350"""Lucy"" Protective Eyewear "1009352025-10-22
D2483552480BurButler (5-Hole Pink Base w/Lid)3552482025-10-22
D2483552490BurButler (5-Hole Purple Base w/Lid)3552492025-10-22
D2483552500BurButler (5-Hole White Base w/Lid)3552502025-10-22
D2483552510BurButler (5-Hole Blue Base w/Lid)3552512025-10-22
D2483552550BurButler (10-Hole Orange Base w/Lid)3552552025-10-22
D2483552570BurButler (10-Hole Black Base w/Lid)3552572025-10-22
D2483552580BurButler (10-Hole Purple Base w/Lid)3552582025-10-22
D2483552590BurButler (25-Hole White Base w/Lid)3552592025-10-22
D2483552610BurButler (25-Hole Purple Base w/Lid)3552612025-10-22
D2483552630BurButler (25-Hole Orange Base w/Lid)3552632025-10-22
D2483552640BurButler (25-Hole Black Base w/Lid)3552642025-10-22
D2483552650BurButler (25-Hole Orange Base w/ Tall Lid)3552652025-10-22
D2483552660BurButler (25-Hole Blue Base w/ Tall Lid)3552662025-10-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
D2486054301MIRABRUSH YELLOW POINTEDHAGER WORLDWIDE, INC.KFX2023-08-04
D2486054300MIRABRUSH YELLOW POINTEDHAGER WORLDWIDE, INC.KFX2023-08-04
D2486054310MIRABRUSH BLUE STRAIGHTHAGER WORLDWIDE, INC.KFX2023-08-04
00840663108916YES TapeLemaitre Vascular, Inc.KFX2021-06-18
00840663110339Vesper Custom TapeLemaitre Vascular, Inc.KFX2021-06-18
00840663100323VascuTape Radiopaque TapeLemaitre Vascular, Inc.KFX2015-06-30
00840663100330VascuTape Radiopaque TapeLemaitre Vascular, Inc.KFX2015-06-30
00840663100347VascuTape Radiopaque TapeLemaitre Vascular, Inc.KFX2015-06-30
00840663100354VascuTape Radiopaque TapeLemaitre Vascular, Inc.KFX2015-06-30
00840663100361VascuTape Radiopaque TapeLemaitre Vascular, Inc.KFX2015-06-30
00840663100378VascuTape Radiopaque TapeLemaitre Vascular, Inc.KFX2015-06-30
00840663100385VascuTape Radiopaque TapeLemaitre Vascular, Inc.KFX2015-06-30
00840663100392VascuTape Radiopaque TapeLemaitre Vascular, Inc.KFX2015-06-30
00840663100408VascuTape Radiopaque TapeLemaitre Vascular, Inc.KFX2015-06-30