FDA.reportPublic FDA data

Darby Dental Supply, LLC

Primary DI
20889813059009
Brand
Darby Dental Supply, LLC
Company
DARBY DENTAL SUPPLY, LLC
Model
9501564
Catalog number
9501564
Device description
ORAL EVACUATOR TIP VENTED DSP
Published
2022-10-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EHZEvacuator, oral cavity

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EHZEvacuator, Oral CavityDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20889813059009PackageGS120In Commercial Distribution
00889813059005PrimaryGS10
10889813059002Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2088981305900920889813059009
00889813059005008898130590058898130590050889813059005
1088981305900210889813059002

GMDN Terms#

Term, Definition table
TermDefinition
Dental suction system cannula, single-useA semi-rigid or rigid hollow tubular component of a dental suction system designed to be inserted into the oral cavity for the aspiration and removal of blood, pus, saliva, debris, and water during a dental procedure. It is typically made of disposable plastic materials. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(516)688-6800Robyn.livingston@darby.com

Regulatory Flags#

DUNS number
825137818
Device count
50
DM exempt
true
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
00723896029848Practicon Color Splash™ Saliva Ejectors 100/PackPRACTICON, INC.EHZ2026-01-08
10371347017790Advance Dental ProductsThe Atlanta Dental Supply CompanyEHZ2025-11-18
10371347017806Advance Dental ProductsThe Atlanta Dental Supply CompanyEHZ2025-11-18
10371347017813Advance Dental ProductsThe Atlanta Dental Supply CompanyEHZ2025-11-18
10371347017820Advance Dental ProductsThe Atlanta Dental Supply CompanyEHZ2025-11-18
00371347018448Advance Dental ProductsThe Atlanta Dental Supply CompanyEHZ2025-03-04
TQ26ST2553121Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EHZ2024-12-09
TQ26ST2553211Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EHZ2024-12-09
TQ26ST2553311Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EHZ2024-12-09
TQ26ST2553411Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EHZ2024-12-09
TQ26ST2553521Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EHZ2024-12-09
TQ26ST2553621Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EHZ2024-12-09
TQ26ST2553721Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EHZ2024-12-09
TQ26ST2553921Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EHZ2024-12-09
10080196553686MEDLINEMEDLINE INDUSTRIES, INC.EHZ2024-09-19
10889950144838Hu-FriedyHU-FRIEDY MFG. CO., LLCEHZ2024-08-15
10889950144845Hu-FriedyHU-FRIEDY MFG. CO., LLCEHZ2024-08-15
10889950144852Hu-FriedyHU-FRIEDY MFG. CO., LLCEHZ2024-08-15
10889950144869Hu-FriedyHU-FRIEDY MFG. CO., LLCEHZ2024-08-15
10889950144876Hu-FriedyHU-FRIEDY MFG. CO., LLCEHZ2024-08-15
10889950144883Hu-FriedyHU-FRIEDY MFG. CO., LLCEHZ2024-08-15
10888277652941MedlineMEDLINE INDUSTRIES, INC.EHZ2024-01-24
D248B101051Saliva Ejector Tip (Gray) - Pack of 10HAGER WORLDWIDE, INC.EHZ2023-09-12
D248B101081Saliva Ejector Tip (Gray) - Pack of 3HAGER WORLDWIDE, INC.EHZ2023-09-12
D248B101120Serviceable Saliva EjectorHAGER WORLDWIDE, INC.EHZ2023-09-12
10889950140717HuFriedyGroupHU-FRIEDY MFG. CO., LLCEHZ2023-05-26
10889950140724HuFriedyGroupHU-FRIEDY MFG. CO., LLCEHZ2023-05-26
H668D6401141PearsonKeystone IndustriesEHZ2023-02-20
H668D6401151PearsonKeystone IndustriesEHZ2023-02-20
H668D6401211PearsonKeystone IndustriesEHZ2023-02-20