FDA.report

Henry Schein

Primary DI
00304040169223
Brand
Henry Schein
Company
HENRY SCHEIN, INC.
Model
5702983
Catalog number
5702983
Device description
Dental floss threaders
Published
2023-06-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
JESFLOSS, DENTAL

Product Code Classifications

CodeDeviceSpecialtyClass
JESFloss, DentalDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10304040169220PrimaryGS10
00304040169223Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1030404016922010304040169220
00304040169223003040401692233040401692230304040169223

GMDN Terms

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

Regulatory Flags

DUNS number
012430880
Device count
10
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
true
Sterilization required before use
false

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Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
06975843620002HIT PROMOTIONAL PRODUCTS, INC.YUYAO NEW POWER PROMOTION INDUSTRIAL CO., LTDJES2026-05-26
16931718175647HIT PROMOTIONAL PRODUCTS, INCNew Phenix Home Products Manufactory Co., Ltd.JES2026-03-03
008171690226333D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCJES2025-12-16
16931718175616HIT PROMOTIONAL PRODUCTS, INC.New Phenix Home Products Manufactory Co., Ltd.JES2025-08-05
D83230000EXPANDII FLOSSIIPLASDENT CORPORATIONJES2025-06-02
D8323000B0EXPANDII FLOSSIIPLASDENT CORPORATIONJES2025-06-02
D8323000T0EXPANDII FLOSSIIPLASDENT CORPORATIONJES2025-06-02
D83231000FINE FLOSSIIPLASDENT CORPORATIONJES2025-06-02
D8323100B0FINE FLOSSIIPLASDENT CORPORATIONJES2025-06-02
D8323100T0FINE FLOSSIIPLASDENT CORPORATIONJES2025-06-02
16931718175609HIT PROMOTIONAL PRODUCTS, INC.New Phenix Home Products Manufactory Co., Ltd.JES2025-05-07
10810051081784GURUNANDA DUAL-SLICKER FLOSS PICKGurunanda, LLCJES2025-05-06
10810051083412GURUNANDA ULTIMATE 2-IN-1 FLOSS & INTERDENTAL PICKGurunanda, LLCJES2025-05-06
00810051085532GURUNANDA EXPANDABLE FLOSSGurunanda, LLCJES2025-05-06
06973026120288MeizhikangMeizhikang Technology (Shenzhen) Co., Ltd.JES2025-04-21
16931718175586HIT PROMOTIONAL PRODUCTS, INC.New Phenix Home Products Manufactory Co., Ltd.JES2025-04-18
00860009239623INNOVATION LINEInnovation SpecialtiesJES2025-04-15
00860009239630INNOVATION LINEInnovation SpecialtiesJES2025-04-15
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20810063756189Waxed Dental FlossSAFCO DENTAL SUPPLY CO.JES2025-03-18
20810063756196Floss PicksSAFCO DENTAL SUPPLY CO.JES2025-03-18
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00359883005696Re-Cord™ Knitted Retraction Cord #000DEN-MAT HOLDINGS, LLCJES2025-03-12
00359883005702Re-Cord™ Knitted Retraction Cord #00DEN-MAT HOLDINGS, LLCJES2025-03-12
00359883005719Re-Cord™ Knitted Retraction Cord #0DEN-MAT HOLDINGS, LLCJES2025-03-12
00359883005726Re-Cord™ Knitted Retraction Cord #1DEN-MAT HOLDINGS, LLCJES2025-03-12
00359883005733Re-Cord™ Knitted Retraction Cord #2DEN-MAT HOLDINGS, LLCJES2025-03-12
00359883005740Re-Cord™ Knitted Retraction Cord #3DEN-MAT HOLDINGS, LLCJES2025-03-12
00304040189818Henry ScheinHENRY SCHEIN, INC.JES2025-01-30