FDA.reportPublic FDA data

GUM®

Primary DI
00070942302159
Brand
GUM®
Company
SUNSTAR AMERICAS, INC.
Model
1812
Catalog number
RQTX
Device description
BUTLERWEAVE DENTAL FLOSS SPECIAL WEAVE 24YD
Published
2022-11-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
JESFLOSS, DENTAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JESFloss, DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10070942302156PackageGS124In Commercial Distribution
00070942302159PrimaryGS10
80070942302155Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1007094230215610070942302156
00070942302159000709423021590709423021590070942302159
8007094230215580070942302155

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height0

Contacts#

Phone, Email table
PhoneEmail
+1(800)777-3101contact.us@us.sunstar.com

Regulatory Flags#

DUNS number
025066358
Device count
2
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
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
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
00070942007412GUM Technique Sensitive Clean527TRA22025-08-15

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
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
00070942008822GUM® Expanding FlossSUNSTAR AMERICAS, INC.JES2026-05-01
00070942008952GUM® Professional Clean FlossSUNSTAR AMERICAS, INC.JES2026-04-30
10070942003695GUM® CRAYOLA TWISTABLES FLOSSERSSUNSTAR AMERICAS, INC.JES2025-11-04
10371347019732Advance Dental ProductsThe Atlanta Dental Supply CompanyJES2025-10-01
10371347019749Advance Dental ProductsThe Atlanta Dental Supply CompanyJES2025-10-01
20371347019531Advance Dental ProductsThe Atlanta Dental Supply CompanyJES2025-06-25
10810063755567Waxed Dental FlossSAFCO DENTAL SUPPLY CO.JES2025-03-18
10810063756182Waxed Dental FlossSAFCO DENTAL SUPPLY CO.JES2025-03-18
10810063756199Floss PicksSAFCO DENTAL SUPPLY CO.JES2025-03-18
10810063756656Waxed Dental FlossSAFCO DENTAL SUPPLY CO.JES2025-03-18
10810063756663Waxed Dental FlossSAFCO DENTAL SUPPLY CO.JES2025-03-18
10304040189853Henry ScheinHENRY SCHEIN, INC.JES2025-01-30
10304040189860Henry ScheinHENRY SCHEIN, INC.JES2025-01-30
10304040189877Henry ScheinHENRY SCHEIN, INC.JES2025-01-30
10304040189884Henry ScheinHENRY SCHEIN, INC.JES2025-01-30
00032251933462Family WellnessFamily Dollar StoresJES2024-05-03