FDA.reportPublic FDA data

COMPLETE DENTAL SUPPLIES

Primary DI
00850055627147
Brand
COMPLETE DENTAL SUPPLIES
Company
Complete Dental Supplies LLC
Model
20470-CDS
Device description
"Cotton Tipped Applicators 6"" 1000 pcs/box"
Published
2023-09-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
KXFApplicator, Absorbent Tipped, Non-Sterile

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KXFApplicator, Absorbent Tipped, Non-SterileGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850055627147PrimaryGS10
00850055627369Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850055627147008500556271478500556271470850055627147
00850055627369008500556273698500556273690850055627369

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose absorbent tip applicator/swab, single-useA hand-held manual device, also known as a cotton bud or swab, in the form of a stick with a single- or double-ended absorbent tip (e.g., cotton pledget), intended for cleaning or applying a substance (e.g., medication) to a superficial wound or body orifice, and/or to take specimens from a patient. It is not dedicated to a particular body area or orifice, and is intended for use in a healthcare setting and/or in the home. This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
054494926
Device count
1000
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850055627000COMPLETE DENTAL SUPPLIES20460-CDS2023-09-06
00850055627154COMPLETE DENTAL SUPPLIES20468-CDS2023-09-06
00850055627406COMPLETE DENTAL SUPPLIES20458-CDS2023-09-22
00850055627581COMPLETE DENTAL SUPPLIES20374-CDS2023-09-25
00850055627598COMPLETE DENTAL SUPPLIES20374-CDS2023-09-25
00850055627178COMPLETE DENTAL SUPPLIES20465-CDS2023-09-22
00850055627383COMPLETE DENTAL SUPPLIES20547-CDS2023-09-22
00850055627420COMPLETE DENTAL SUPPLIES20367-CDS2023-09-22
00850055627444COMPLETE DENTAL SUPPLIES20368-CDS2023-09-22
00850055627468COMPLETE DENTAL SUPPLIES20472-CDS2023-09-22
00850055627482COMPLETE DENTAL SUPPLIES20473-CDS2023-09-22
00850055627505COMPLETE DENTAL SUPPLIES20474-CDS2023-09-22
00850055627529COMPLETE DENTAL SUPPLIES20475-CDS2023-09-22
00850055627543COMPLETE DENTAL SUPPLIES20476-CDS2023-09-22
00850055627567COMPLETE DENTAL SUPPLIES20477-CDS2023-09-22
00850055627369COMPLETE DENTAL SUPPLIES20470-CDS2023-09-22
00850055627376COMPLETE DENTAL SUPPLIES20465-CDS2023-09-22
00850055627390COMPLETE DENTAL SUPPLIES20547-CDS2023-09-22
00850055627413COMPLETE DENTAL SUPPLIES20458-CDS2023-09-22
00850055627437COMPLETE DENTAL SUPPLIES20367-CDS2023-09-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10889483563267BALLARD™SUNMED, LLCKXF2026-01-12
10889483563281BALLARD™SUNMED, LLCKXF2026-01-12
10889483563311BALLARD™SUNMED, LLCKXF2026-01-12
10889483563335BALLARD™SUNMED, LLCKXF2026-01-12
10889483563359BALLARD™SUNMED, LLCKXF2026-01-12
07613327680720Q-CareSAGE PRODUCTS, LLCKXF2025-12-03
07613327680737Q-CareSAGE PRODUCTS, LLCKXF2025-12-03
07613327680744Q-CareSAGE PRODUCTS, LLCKXF2025-12-03
07613327680751Q-CareSAGE PRODUCTS, LLCKXF2025-12-03
10889483563274BALLARD™SUNMED, LLCKXF2025-11-17
10889483563298BALLARD™SUNMED, LLCKXF2025-11-17
10889483563328BALLARD™SUNMED, LLCKXF2025-11-17
10889483563342BALLARD™SUNMED, LLCKXF2025-11-17
10889483565520BALLARD™SUNMED, LLCKXF2025-11-17
10889483565537BALLARD™SUNMED, LLCKXF2025-11-17
10889483565544BALLARD™SUNMED, LLCKXF2025-11-17
M220761002Pro AdvantageNATIONAL DISTRIBUTION & CONTRACTING, INC.KXF2025-09-11
D832600BA4001MAXAPPLICATOR IIPLASDENT CORPORATIONKXF2025-08-01
D832600BF4001MAXAPPLICATOR IIPLASDENT CORPORATIONKXF2025-08-01
10840330701454ProCureTwin Med, LLCKXF2024-11-14
10840330701461ProCureTwin Med, LLCKXF2024-11-14
10840330701478ProCureTwin Med, LLCKXF2024-11-14
10840330701485ProCureTwin Med, LLCKXF2024-11-14
00616784430713"DynaSafety Cotton-Tipped Applicators in Sealed Vial,3"""Dynarex CorporationKXF2024-11-11
00087701406973Good NeighborU.S. COTTON, LLCKXF2024-07-30
00817522013377SwabezeKENTEC MEDICAL, INC.KXF2024-06-28
00817522013353SwabezeKENTEC MEDICAL, INC.KXF2024-06-27
00817522013360SwabezeKENTEC MEDICAL, INC.KXF2024-06-27
00817522013384SwabezeKENTEC MEDICAL, INC.KXF2024-06-27
10817522013343SwabezeKENTEC MEDICAL, INC.KXF2024-06-20