FDA.reportPublic FDA data

GUM

Primary DI
00070942007498
Brand
GUM
Company
SUNSTAR AMERICAS, INC.
Model
KIT56
Device description
Sample Kit containing 135RA1 Multi-Clean Toothbrush828PQ Twisted Mint® Floss Picks sample pack649PA Soft-Picks® Advanced Tight sample pack
Published
2024-10-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
EFWToothbrush, Manual
JESFloss, Dental
JETPick, Massaging

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EFWToothbrush, ManualDental1
JESFloss, DentalDental1
JETPick, MassagingDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00070942007498PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00070942007498000709420074980709420074980070942007498

GMDN Terms#

Term, Definition table
TermDefinition
Dental flossA string-like device formed as thread or tape, used for the removal of plaque and/or debris from the proximal surfaces of teeth and the gingival surfaces of fixed prostheses. It is typically made of a synthetic fibre. After application, this device cannot be reused.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
025066358
Device count
1
Premarket exempt
true
Kit
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00070942007160GUM®888PCRX2026-10-08
07640164360072GUIDORC11-0082015-10-22
07640164360089GUIDORC11-0182015-10-22
07640164360096GUIDORC11-0782015-10-22
07640164360140GUIDORC11-0072015-10-22
10070942003695GUM® CRAYOLA TWISTABLES FLOSSERS853PA, PX2025-11-04
10070942751572GUM®2014PQ, PQA, PQB2022-11-10
10070942751619GUM®1115PQA; PQBX2022-11-10
70070942751703GUM®3210PQX2022-11-10
00070942302159GUM®1812RQTX2022-11-10
00070942306515GUM®897RQ75, RZDX2022-11-10
00070942008334GUM®875SM2026-07-28
00070942005265GUM®3615BQ2023-01-26
00070942006491GUM®3615PQA2023-12-07
00070942005425GUM®4100UTWA2023-06-14
00070942005432GUM®4100UTBA2023-06-14
00070942008822GUM® Expanding Floss2030R42026-05-01
00070942008952GUM® Professional Clean Floss1820RA2026-04-30
00070942783354GUM®9934RA2024-03-12
00070942007368GUM Technique Sensitive Clean527TPA12025-08-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06931718193910nature FreshNew Phenix Home Products Manufactory Co., Ltd.JES2026-10-15
00070942007160GUM®SUNSTAR AMERICAS, INC.JES2026-10-08
00818746020042Gingi-Plain Max Soft-TwistGingi PakJES2026-08-26
00818746020073Gingi-Plain Max Z-TwistGingi PakJES2026-08-26
00818746020080Gingi-Plain Max Z-TwistGingi PakJES2026-08-26
00818746020097Gingi-Plain Max Z-TwistGingi PakJES2026-08-26
00818746020103Gingi-Plain Max Z-TwistGingi PakJES2026-08-26
08800017900155DX-Ultra Ultrasonic IrrigationDXM CO., LTDJET2026-08-21
08800017902500DX-Ultra Ultrasonic IrrigationDXM CO., LTDJET2026-08-21
00840456224762JMUJMU DENTAL, INCJES2026-08-18
00070942008334GUM®SUNSTAR AMERICAS, INC.JES2026-07-28
00840456214701JMUJMU DENTAL, INCJES2026-07-24
00840456214718JMUJMU DENTAL, INCJES2026-07-24
06931718175657HIT PROMOTIONAL PRODUCTS, INC.New Phenix Home Products Manufactory Co., Ltd.JES2026-06-23
06931718175664HIT PROMOTIONAL PRODUCTS, INC.New Phenix Home Products Manufactory Co., Ltd.JES2026-06-23
06931718175671HIT PROMOTIONAL PRODUCTS, INC.New Phenix Home Products Manufactory Co., Ltd.JES2026-06-23
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