FDA.reportPublic FDA data

Microbrush

Primary DI
10789594000364
Brand
Microbrush
Company
YOUNG MICROBRUSH, LLC
Model
PR400-KIT
Published
2020-12-08
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

Product Codes#

Code, Name table
CodeName
KXRAPPLICATOR, RESIN

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KXRApplicator, ResinDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10789594000364PackageGS1400In Commercial Distribution
20789594000361PackageGS124In Commercial Distribution
00789594000367PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1078959400036410789594000364
2078959400036120789594000361
00789594000367007895940003677895940003670789594000367

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose absorbent tip applicator/swab, single-useA hand-held manual device, also known as a cotton bud or swab, in the form of a stick made of wood, paper, or plastic, with a single- or double-ended absorbent tip (e.g., cotton pledget), intended for cleaning or applying a substance (e.g., medication) to a superficial wound or body orifice, and to take specimens from a patient. It is not dedicated to a particular body area or orifice, and is used in a healthcare setting and in the home. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
929236305
Device count
1
DM exempt
false
Premarket exempt
true
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00789594000442MicrobrushWMFP100WMFP1002020-12-08
00789594000459MicrobrushWMFP100-SWMFP100-S2020-12-08
00789594000466MicrobrushWMFY100WMFY1002020-12-08
00789594000473MicrobrushWMFY100-SWMFY100-S2020-12-08
00789594000480MicrobrushWMRB100WMRB1002020-12-08
00789594000497MicrobrushWMRB100-SWMRB100-S2020-12-08
00789594000503MicrobrushWMRG100WMRG1002020-12-08
00789594000510MicrobrushWMRG100-SWMRG100-S2020-12-08
00789594000527MicrobrushWMRPE100WMRPE1002020-12-08
00789594000534MicrobrushWMRPE100-SWMRPE100-S2020-12-08
00789594000541MicrobrushWMRPU100WMRPU1002020-12-08
00789594000558MicrobrushWMRPU100-SWMRPU100-S2020-12-08
00789594000565MicrobrushWMSF100WMSF1002020-12-08
00789594000572MicrobrushWMSF100-SWMSF100-S2020-12-08
00789594000206MicrobrushMBX-SAMPLE2020-12-08
00789594000213MicrobrushMD-SAMPLE/72020-12-08
00789594000732SmartBands2915902020-12-08
00789594000749SmartBands2915912020-12-08
00789594000756SmartBands2915922020-12-08
00789594000763SmartBands2915932020-12-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810194403293AiraAIRA, LLCKXR2026-08-25
00810194403309AiraAIRA, LLCKXR2026-08-25
00810194403323AiraAIRA, LLCKXR2026-08-25
00810194403330AiraAIRA, LLCKXR2026-08-25
00840456202555JMUJMU DENTAL, INCKXR2026-07-27
00840456202562JMUJMU DENTAL, INCKXR2026-07-27
00840456202579JMUJMU DENTAL, INCKXR2026-07-27
00840456202586JMUJMU DENTAL, INCKXR2026-07-27
00840456202593JMUJMU DENTAL, INCKXR2026-07-27
00840456218006JMUJMU DENTAL, INCKXR2026-07-27
00840456218013JMUJMU DENTAL, INCKXR2026-07-27
00840456218020JMUJMU DENTAL, INCKXR2026-07-27
00840456218037JMUJMU DENTAL, INCKXR2026-07-27
00840456202401JMUJMU DENTAL, INCKXR2026-07-08
00840456223222JMUJMU DENTAL, INCKXR2026-07-08
00840456223239JMUJMU DENTAL, INCKXR2026-07-08
D1257500B2Premium PlusPremium Plus (Dongguan) LimitedKXR2026-05-21
D1257500G2Premium PlusPremium Plus (Dongguan) LimitedKXR2026-05-21
D1257500L2Premium PlusPremium Plus (Dongguan) LimitedKXR2026-05-21
D1257500Y2Premium PlusPremium Plus (Dongguan) LimitedKXR2026-05-21
D1257501B2Premium PlusPremium Plus (Dongguan) LimitedKXR2026-05-21
D1257501G2Premium PlusPremium Plus (Dongguan) LimitedKXR2026-05-21
D1257501L2Premium PlusPremium Plus (Dongguan) LimitedKXR2026-05-21
D1257501Y2Premium PlusPremium Plus (Dongguan) LimitedKXR2026-05-21
D1257502T4Premium PlusPremium Plus (Dongguan) LimitedKXR2026-05-21
D1257502W4Premium PlusPremium Plus (Dongguan) LimitedKXR2026-05-21
D1257510B2Premium PlusPremium Plus (Dongguan) LimitedKXR2026-05-21
D1257510G2Premium PlusPremium Plus (Dongguan) LimitedKXR2026-05-21
D1257510L2Premium PlusPremium Plus (Dongguan) LimitedKXR2026-05-21
D1257510Y2Premium PlusPremium Plus (Dongguan) LimitedKXR2026-05-21