FDA.reportPublic FDA data

SmartBands

Primary DI
00789594000756
Brand
SmartBands
Company
YOUNG MICROBRUSH, LLC
Model
291592
Published
2020-12-08
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
DZNINSTRUMENTS, DENTAL HAND

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZNInstruments, Dental HandDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10789594000753PackageGS1100Not in Commercial Distribution
20789594000750PackageGS112Not in Commercial Distribution
00789594000756PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1078959400075310789594000753
2078959400075020789594000750
00789594000756007895940007567895940007560789594000756

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 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/or to take specimens from a patient. It is not dedicated to a particular body area or orifice, and is intended for use in a healthcare setting and/or in the home. This is a single-use device.

Regulatory Flags#

DUNS number
929236305
Device count
1
Premarket exempt
true
Lot or batch
true

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
00789594000763SmartBands2915932020-12-08
00789594000770ContactPro2917042020-12-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810226102231AiraAIRA, LLCDZN2026-08-26
00810226102248AiraAIRA, LLCDZN2026-08-26
00198506092688ELMED INCORPORATEDELMED INCORPORATEDDZN2026-07-28
E0HM39MI2071Bone ManagementHager & Meisinger Gesellschaft mit beschränkter HaftungDZN2026-07-24
E0HM39MI2081Bone ManagementHager & Meisinger Gesellschaft mit beschränkter HaftungDZN2026-07-24
00190776403867MillenniumAvalign Technologies, Inc.DZN2026-07-21
10860013564701CurvaGc Orthodontics America Inc.DZN2026-05-28
10860013564718CurvaGc Orthodontics America Inc.DZN2026-05-28
10860013564725CurvaGc Orthodontics America Inc.DZN2026-05-28
10860013564732CurvaGc Orthodontics America Inc.DZN2026-05-28
10860013564756CurvaGc Orthodontics America Inc.DZN2026-05-28
10860013564763CurvaGc Orthodontics America Inc.DZN2026-05-28
10860013564770CurvaGc Orthodontics America Inc.DZN2026-05-28
07898488905190INSTRUMENT FOR ICERAM SLB BRACKETORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZN2026-05-27
07908611211187CERAMIC NANO TUBE TWEEZERORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZN2026-05-27
07908611211255CURVERD SCISSORS FOR ALIGNERSORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZN2026-05-27
G149TBSB7500TBS BASICSACME ENTERPRISE.DZN2026-05-21
G149TBSB7510TBS BASICSACME ENTERPRISE.DZN2026-05-21
G149TBSB7520TBS BASICSACME ENTERPRISE.DZN2026-05-21
G149TBSB7530TBS BASICSACME ENTERPRISE.DZN2026-05-21
08404535018929Brasseler USAPeter Brasseler Holdings, LLCDZN2026-04-29
08404535018950Brasseler USAPeter Brasseler Holdings, LLCDZN2026-04-29
08404535019049Brasseler USAPeter Brasseler Holdings, LLCDZN2026-04-29
08404535019070Brasseler USAPeter Brasseler Holdings, LLCDZN2026-04-29
08404535019131Brasseler USAPeter Brasseler Holdings, LLCDZN2026-04-29
08404535019162Brasseler USAPeter Brasseler Holdings, LLCDZN2026-04-29
07908854000647Supremo InstrumentosANDRE GREGATE BRAGA INSTRUMENTOS LTDADZN2025-05-22
07908854000654Supremo InstrumentosANDRE GREGATE BRAGA INSTRUMENTOS LTDADZN2025-05-22
07908854000661Supremo InstrumentosANDRE GREGATE BRAGA INSTRUMENTOS LTDADZN2025-05-22
07908854000678Supremo InstrumentosANDRE GREGATE BRAGA INSTRUMENTOS LTDADZN2025-05-22