FDA.reportPublic FDA data

Uni-Tip Long -Package of 25

Primary DI
00014081016379
Brand
Uni-Tip Long -Package of 25
Company
HAGER WORLDWIDE, INC.
Model
B1637
Device description
Chrome-plated air/water syringe
Published
2023-03-08
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
false

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
00014081016379PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00014081016379000140810163790140810163790014081016379

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
1
DM exempt
true
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
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D248938520Uni-Wedge Regular ( Orange)938522026-01-28
D2486300620TS1 Tongue Vacuum Cleaner6300622024-08-20
D2483552470The Prepster (also known as LaminateButler)3552472024-07-15
D2483552520BurButler ( 5 Hole Orange Base w/Lid)3552522024-07-15
D2483552530BurButler ( 10 Hole White Base w/Lid)3552532024-07-15
D2483552540BurButler ( 10 Hole Pink Base w/Lid)3552542024-07-15
D2483552560BurButler ( 10 Hole Blue Base w/Lid)3552562024-07-15
D2483552600BurButler ( 25 Hole Pink Base w/Lid)3552602024-07-15
D2483552620BurButler ( 25 Hole Blue Base w/Lid)3552622024-07-15
D2486054510Mirahold Child6054512024-07-03
D248137720Almore Aluminum Oxide137722024-05-20
D248137730Almore Aluminum Oxide137732024-05-20
D248B1619B0DurationB16212024-05-20
D248B16280Uni-TipB1629C2024-05-20
D2481550180Reso-Pac Hydrophilic Periodontal Dressing1550182016-09-22
D2481550190Reso-Pac Hydrophilic Periodontal Dressing1550192016-09-22
D2483553190Plast Frame3553192024-04-16
D248222300SafeDispense - Silver222302024-04-12
D248222310Mini SafeDispense222312024-04-12
D248222360SafeDispense - White222362024-04-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810208581269NuCareNuCare LLCECB2026-02-03
10810208581266NuCareNuCare LLCECB2026-02-03
20810208581263NuCareNuCare LLCECB2026-02-03
E89627160SCHWERTA. Schweickhardt GmbH & Co. KGECB2025-04-07
03760243009907Classic by RISKONTROLPRODUITS DENTAIRES PIERRE ROLLANECB2025-04-01
10840326423674AstekYoung Innovations, Inc.ECB2025-02-07
00810021436722DCIDCI International, LLCECB2024-12-13
00810021436739DCIDCI International, LLCECB2024-12-13
00810021436746DCIDCI International, LLCECB2024-12-13
00850048528864Amtouch Air/Water Syringe TipsAMERICAN MEDICAL & HOSPITAL SUPPLY CO., INC.ECB2024-10-08
00850048528901Amtouch Air/Water Syringe TipsAMERICAN MEDICAL & HOSPITAL SUPPLY CO., INC.ECB2024-10-08
00850048528918Amtouch Air/Water Syringe TipsAMERICAN MEDICAL & HOSPITAL SUPPLY CO., INC.ECB2024-10-08
00810021433783DCIDCI International, LLCECB2024-08-02
D930205010020JMUJMU DENTAL, INCECB2024-06-27
00810021435947DCIDCI International, LLCECB2024-05-24
20810021435958DCIDCI International, LLCECB2024-05-24
D248B1619B0DurationHAGER WORLDWIDE, INC.ECB2024-05-20
D248B16280Uni-TipHAGER WORLDWIDE, INC.ECB2024-05-20
E8962702090SCHWERTA. Schweickhardt GmbH & Co. KGECB2024-05-16
00810021434216DCIDCI International, LLCECB2024-05-13
00810021435466DCIDCI International, LLCECB2024-05-13
00810021435534DCIDCI International, LLCECB2024-05-13
00810021435541DCIDCI International, LLCECB2024-05-13
00810021435589DCIDCI International, LLCECB2024-05-13
00810021435602DCIDCI International, LLCECB2024-05-13
00810021435633DCIDCI International, LLCECB2024-05-13
00810021435640DCIDCI International, LLCECB2024-05-13
00810021435664DCIDCI International, LLCECB2024-05-13
00810021435671DCIDCI International, LLCECB2024-05-13
00810021435688DCIDCI International, LLCECB2024-05-13