FDA.reportPublic FDA data

MIRABRUSH YELLOW POINTED

Primary DI
D2486054300
Brand
MIRABRUSH YELLOW POINTED
Company
HAGER WORLDWIDE, INC.
Model
605430
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
Rx
false
OTC
false
Sterile
false
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
D2486054301PrimaryHIBCC0
D2486054300Unit 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.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
009277971
Device count
100
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
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 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
D2486054311MIRABRUSH BLUE STRAIGHTHAGER 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