FDA.reportPublic FDA data

Darby Dental Supply, LLC

Primary DI
10889813060466
Brand
Darby Dental Supply, LLC
Company
DARBY DENTAL SUPPLY, LLC
Model
9900038
Device description
SYRINGE TIP METAL AR/WTR 3WAY
Published
2023-10-31
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

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
00889813060469PrimaryGS10
10889813060466Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889813060469008898130604698898130604690889813060469
1088981306046610889813060466

GMDN Terms#

Term, Definition table
TermDefinition
Dental delivery system irrigation handpieceA hand-held device that is used to regulate and direct a stream of pressurized, warmed water and/or air for the purpose of irrigating/clearing debris from the field of operation in the oral cavity during restorative or operative dental procedures. It is fitted with a long syringe-like nozzle that is activated by the user, typically through push-type controls. This device, also commonly known as a three-way or a Triplex syringe, is typically a component of a dental delivery system from which the air and water is supplied. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
825137818
Device count
5
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00889813067970Darby Dental Supply, LLC95377462026-03-22
00889813067987Darby Dental Supply, LLC95377502026-03-22
00889813067994Darby Dental Supply, LLC525879552587952026-02-12
00889813068007Darby Dental Supply, LLC525879652587962026-02-12
00889813068021Darby Dental Supply, LLC525879752587972026-02-12
00889813068038Darby Dental Supply, LLC525879852587982026-02-12
00889813068045Darby Dental Supply, LLC525879952587992026-02-12
00889813068052Darby Dental Supply, LLC525879052587902026-02-12
00889813068069Darby Dental Supply, LLC525879152587912026-02-12
00889813068076Darby Dental Supply, LLC525879252587922026-02-12
00889813068083Darby Dental Supply, LLC525879352587932026-02-12
00889813068090Darby Dental Supply, LLC525879452587942026-02-12
00889813048566Darby Dental Supply, LLC943020394302032022-07-18
00889813048580Darby Dental Supply, LLC943020494302042022-07-18
00889813048610Darby Dental Supply, LLC943020594302052022-07-18
00889813048672Darby Dental Supply, LLC943021094302102022-07-18
00889813048696Darby Dental Supply, LLC943021194302112022-07-18
00889813048719Darby Dental Supply, LLC943021294302122022-07-18
00889813048443Darby Dental Supply, LLC943020294302022022-07-18
00889813048511Darby Dental Supply, LLC943020194302012022-07-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810194402845AiraAIRA, LLCECB2026-08-26
00810194402852AiraAIRA, LLCECB2026-08-26
00810194402876AiraAIRA, LLCECB2026-08-26
00810194402883AiraAIRA, LLCECB2026-08-26
00810194402890AiraAIRA, LLCECB2026-08-26
00840456224465JMUJMU DENTAL, INCECB2026-07-24
00810230800116DCI PartsDCI International, LLCECB2026-06-26
00810230800123DCI PartsDCI International, LLCECB2026-06-26
00810230800130DCI PartsDCI International, LLCECB2026-06-26
00810230800147DCI PartsDCI International, LLCECB2026-06-26
00810230800154DCI PartsDCI International, LLCECB2026-06-26
00810230800161DCI PartsDCI International, LLCECB2026-06-26
00810230800178DCI PartsDCI International, LLCECB2026-06-26
00810230800185DCI PartsDCI International, LLCECB2026-06-26
00810230800192DCI PartsDCI International, LLCECB2026-06-26
00810230800208DCI PartsDCI International, LLCECB2026-06-26
00810230800215DCI PartsDCI International, LLCECB2026-06-26
00810230800222DCI PartsDCI International, LLCECB2026-06-26
00810230800239DCI PartsDCI International, LLCECB2026-06-26
00810230800246DCI PartsDCI International, LLCECB2026-06-26
00810230800253DCI PartsDCI International, LLCECB2026-06-26
00810230800260DCI PartsDCI International, LLCECB2026-06-26
00810230800277DCI PartsDCI International, LLCECB2026-06-26
00810230800284DCI PartsDCI International, LLCECB2026-06-26
00810230800291DCI PartsDCI International, LLCECB2026-06-26
00810230800307DCI PartsDCI International, LLCECB2026-06-26
00810230800314DCI PartsDCI International, LLCECB2026-06-26
00810230800321DCI PartsDCI International, LLCECB2026-06-26
00810230800338DCI PartsDCI International, LLCECB2026-06-26
00810230800345DCI PartsDCI International, LLCECB2026-06-26