FDA.reportPublic FDA data

FOCU-TIP NO.8 (SET/2) WHITE LIGHT INTENSIFYING TIP

Primary DI
D2483550871
Brand
FOCU-TIP NO.8 (SET/2) WHITE LIGHT INTENSIFYING TIP
Company
HAGER WORLDWIDE, INC.
Model
355087
Device description
FOCU-TIP NO.8 (SET/2) WHITE LIGHT INTENSIFYING TIP
Published
2023-05-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
EAYLIGHT, FIBER OPTIC, DENTAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EAYLight, Fiber Optic, DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D2483550871PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
LED dental light, battery-poweredA battery-powered device designed for use in dentistry to project an intense and focused beam of light directly into or around the oral cavity of a patient via a light-emitting diode (LED), situated as the light head at the distal end of the device's light wand, to illuminate the site of a dental examination or procedure. The light head is connected to a light-intensity control unit, containing rechargeable batteries, via a flexible cable; for oral cavity illumination, the light wand may be attached to a suction cannula, a dental chair headrest, or to a retractor hooked on the patient's lower jaw. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(828)624-3319d.pritchard@hagerworldwide.com

Regulatory Flags#

DUNS number
009277971
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D2486058711Hager Prophy Brush Regular Flat6058712026-05-12
D2486058701Hager Prophy Brush Fine Flat6058702026-05-12
D248938521Uni-Wedge Regular ( Orange)938522026-01-28
D248938520Uni-Wedge Regular ( Orange)938522026-01-28
D2481009320"""Heidi"" Protective Eyewear "1009322025-10-22
D2481009330"""Ella"" Protective Eyewear "1009332025-10-22
D2481009350"""Lucy"" Protective Eyewear "1009352025-10-22
D2483552480BurButler (5-Hole Pink Base w/Lid)3552482025-10-22
D2483552490BurButler (5-Hole Purple Base w/Lid)3552492025-10-22
D2483552500BurButler (5-Hole White Base w/Lid)3552502025-10-22
D2483552510BurButler (5-Hole Blue Base w/Lid)3552512025-10-22
D2483552550BurButler (10-Hole Orange Base w/Lid)3552552025-10-22
D2483552570BurButler (10-Hole Black Base w/Lid)3552572025-10-22
D2483552580BurButler (10-Hole Purple Base w/Lid)3552582025-10-22
D2483552590BurButler (25-Hole White Base w/Lid)3552592025-10-22
D2483552610BurButler (25-Hole Purple Base w/Lid)3552612025-10-22
D2483552630BurButler (25-Hole Orange Base w/Lid)3552632025-10-22
D2483552640BurButler (25-Hole Black Base w/Lid)3552642025-10-22
D2483552650BurButler (25-Hole Orange Base w/ Tall Lid)3552652025-10-22
D2483552660BurButler (25-Hole Blue Base w/ Tall Lid)3552662025-10-22

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00814005023380MDPQuality Aspirators, Inc.EAY2025-02-27
00814005023403Minn-SQuality Aspirators, Inc.EAY2025-02-27
00814005023489PE-FOQuality Aspirators, Inc.EAY2025-02-27
00814005023748Seldin 23-FOQuality Aspirators, Inc.EAY2025-02-27
00814005024349HDP-02Quality Aspirators, Inc.EAY2025-02-27
00814005024363MR-FOQuality Aspirators, Inc.EAY2025-02-27
04719883751348APOZAAPOZA ENTERPRISE CO., LTD.EAY2023-06-26
04719883751362APOZAAPOZA ENTERPRISE CO., LTD.EAY2023-06-26
04719883751331APOZAAPOZA ENTERPRISE CO., LTD.EAY2023-06-21
04719883751355APOZAAPOZA ENTERPRISE CO., LTD.EAY2023-06-21
D2483550861FOCU-TIP NO.9.5 (SET/2) WHITE LIGHT INTENSIFYING TIPHAGER WORLDWIDE, INC.EAY2023-05-12
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