FDA.report

QUICK-TIPS (1000/BX) [10 packs =1000]

Primary DI
D2486052200
Brand
QUICK-TIPS (1000/BX) [10 packs =1000]
Company
HAGER WORLDWIDE, INC.
Model
605222
Device description
Micro applicator tip
Published
2023-08-04
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
KXFAPPLICATOR, ABSORBENT TIPPED, NON-STERILE

Product Code Classifications

CodeDeviceSpecialtyClass
KXFApplicator, Absorbent Tipped, Non-SterileGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D2486052221PrimaryHIBCC0
D2486052200Unit of UseHIBCC0

GMDN Terms

TermDefinition
Dental material application tool, single-useA hand-held manual dental instrument intended to be used for the application of a dental restorative material (e.g., amalgam, resin) to a patient’s tooth/teeth; the restorative material is not included. It includes a handle with an application tip/brush which holds the material on its surface/bristles; it is not a syringe- or pistol-like device. This is a single-use device.

Sterilization Methods

Method

Contacts

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

Regulatory Flags

DUNS number
009277971
Device count
1000
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

Other Devices From This Company

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 DIBrandCompanyProduct codePublished
57613327680756Q-CareSAGE PRODUCTS, LLCKXF2025-12-03
30889483563278BALLARD™SUNMED, LLCKXF2025-11-17
30889483563292BALLARD™SUNMED, LLCKXF2025-11-17
10889483563304BALLARD™SUNMED, LLCKXF2025-11-17
30889483563322BALLARD™SUNMED, LLCKXF2025-11-17
30889483563346BALLARD™SUNMED, LLCKXF2025-11-17
30889483565524BALLARD™SUNMED, LLCKXF2025-11-17
30889483565531BALLARD™SUNMED, LLCKXF2025-11-17
30889483565548BALLARD™SUNMED, LLCKXF2025-11-17
M220761003Pro AdvantageNATIONAL DISTRIBUTION & CONTRACTING, INC.KXF2025-09-11
D832600BA4000MAXAPPLICATOR IIPLASDENT CORPORATIONKXF2025-08-01
D832600BF4000MAXAPPLICATOR IIPLASDENT CORPORATIONKXF2025-08-01
D832600BR4000MAXAPPLICATOR IIPLASDENT CORPORATIONKXF2025-08-01
D832600BSF4000MAXAPPLICATOR IIPLASDENT CORPORATIONKXF2025-08-01
00840456214893JMUJMU DENTAL, INCKXF2025-07-15
00840456214909JMUJMU DENTAL, INCKXF2025-07-15
00840456214930JMUJMU DENTAL, INCKXF2025-07-15
00840456209127JMUJMU DENTAL, INCKXF2025-06-17
00840456209134JMUJMU DENTAL, INCKXF2025-06-17
00840456209141JMUJMU DENTAL, INCKXF2025-06-17
00840456213742JMUJMU DENTAL, INCKXF2025-06-17
00840456213759JMUJMU DENTAL, INCKXF2025-06-17
00840456213766JMUJMU DENTAL, INCKXF2025-06-17
00840456213773JMUJMU DENTAL, INCKXF2025-06-17
00840456213780JMUJMU DENTAL, INCKXF2025-06-17
00840456213797JMUJMU DENTAL, INCKXF2025-06-17
00848253004037StomaSoft Cleaning SwabsFreudenberg Medical, LLCKXF2025-03-17
00854498007047SmartPracticeSmarthealth, Inc.KXF2025-02-17
30840330701458ProCureTwin Med, LLCKXF2024-11-14
30840330701465ProCureTwin Med, LLCKXF2024-11-14