FDA.reportPublic FDA data

Uni-Tip -Package of 25

Primary DI
D248B16351
Brand
Uni-Tip -Package of 25
Company
HAGER WORLDWIDE, INC.
Model
B1635
Device description
Chrome-plated air/water syringe
Published
2023-09-12
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
ECBUNIT, SYRINGE, AIR AND/OR WATER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ECBUnit, Syringe, Air And/Or WaterDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D248B16280Direct MarkingHIBCC0
D248B16351PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental delivery system irrigation handpiece tipA rigid, tubular device intended to be fitted to the distal end of a dental delivery system irrigation handpiece (not included) to direct a stream of pressurized, warmed water and/or air to the field of operation in the oral cavity to irrigate/clear debris during a restorative or operative dental procedure. This is a single use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

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

Regulatory Flags#

DUNS number
009277971
Device count
25
Premarket exempt
true
Lot or batch
true
Sterilization required before use
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
30810021439403DCIDCI International, LLCECB2025-11-19
00840326423677AstekYoung Innovations, Inc.ECB2025-02-07
TQ26SYT253721Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.ECB2024-12-09
D248B16201DurationHAGER WORLDWIDE, INC.ECB2024-05-20
D248B16211DurationHAGER WORLDWIDE, INC.ECB2024-05-20
D248B1629C1Uni-TipHAGER WORLDWIDE, INC.ECB2024-05-20
00810339031176SAFE DENTBGSS Company Inc.ECB2024-05-01
00810339031251SAFE DENTBGSS Company Inc.ECB2024-05-01
00810339031374SAFE DENTBGSS Company Inc.ECB2024-05-01
00854014003577SAFE DENTBGSS Company Inc.ECB2024-05-01
00854014003607SAFE DENTBGSS Company Inc.ECB2024-05-01
00840326421994AstekYoung Innovations, Inc.ECB2023-12-01
00840326422007AstekYoung Innovations, Inc.ECB2023-12-01
00840326422014AstekYoung Innovations, Inc.ECB2023-12-01
00840326422021AstekYoung Innovations, Inc.ECB2023-12-01
00840326422045AstekYoung Innovations, Inc.ECB2023-12-01
00840326422052AstekYoung Innovations, Inc.ECB2023-12-01
00840326422069AstekYoung Innovations, Inc.ECB2023-12-01
00840326422076AstekYoung Innovations, Inc.ECB2023-12-01
00840326422083AstekYoung Innovations, Inc.ECB2023-12-01
00840326422090AstekYoung Innovations, Inc.ECB2023-12-01
00840326422106AstekYoung Innovations, Inc.ECB2023-12-01
00840326422113AstekYoung Innovations, Inc.ECB2023-12-01
D248B16291Uni-Tip -Package of 3HAGER WORLDWIDE, INC.ECB2023-09-12
D248B16311Access-Tips -Package of 3HAGER WORLDWIDE, INC.ECB2023-09-12
D248B16331Uni-Tip -Package of 100HAGER WORLDWIDE, INC.ECB2023-09-12
D248B16341Access-Tips -Package of 100HAGER WORLDWIDE, INC.ECB2023-09-12
D248B16361Access-Tips -Package of 25HAGER WORLDWIDE, INC.ECB2023-09-12
D248BOA124P10001Uni-Tip -Package of 5HAGER WORLDWIDE, INC.ECB2023-09-12
10732224001675Sparkle Air Water Syringe TipsCROSSTEX INTERNATIONAL, INC.ECB2023-07-17