FDA.report

Ultimate Flosser (Blue fork with White Body)

Primary DI
D248222210
Brand
Ultimate Flosser (Blue fork with White Body)
Company
HAGER WORLDWIDE, INC.
Model
22221
Device description
Floss Holder/dispenser
Published
2023-03-30
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

Related Records

Contact Domains

Product Codes

CodeName
JESFLOSS, DENTAL

Product Code Classifications

CodeDeviceSpecialtyClass
JESFloss, DentalDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D248222210PrimaryHIBCC0

GMDN Terms

TermDefinition
Dental floss dispenserA manual device, similar to a bench tape dispenser, intended to be used to hold and facilitate the cutting of dental floss sections by an operator, typically with minimal contact to prevent cross-contamination; it is intended for use in a clinical setting or in the home. This is a reusable device.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(828)624-3319d.pritchard@hagerworldwide.com

Regulatory Flags

DUNS number
009277971
Device count
1
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

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D248222300SafeDispense - Silver222302024-04-12
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D248222360SafeDispense - White222362024-04-12

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
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
20810063755564Waxed Dental FlossSAFCO DENTAL SUPPLY CO.JES2025-03-18
20810063756189Waxed Dental FlossSAFCO DENTAL SUPPLY CO.JES2025-03-18
20810063756196Floss PicksSAFCO DENTAL SUPPLY CO.JES2025-03-18
20810063756653Waxed Dental FlossSAFCO DENTAL SUPPLY CO.JES2025-03-18
20810063756660Waxed Dental FlossSAFCO DENTAL SUPPLY CO.JES2025-03-18
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
00304040189825Henry ScheinHENRY SCHEIN, INC.JES2025-01-30