FDA.reportPublic FDA data

Argyle

Primary DI
10884521020337
Brand
Argyle
Company
Cardinal Health, Inc.
Model
8881450004
Catalog number
8881450004
Device description
Saliva Ejector Flexible Lightweight Vinyl
Published
2018-06-30
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Product Codes#

Code, Name table
CodeName
DYNMouthpiece, saliva ejector

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DYNMouthpiece, Saliva EjectorDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20884521020334PackageGS11000Not in Commercial Distribution
10884521020337PrimaryGS10
30884521020331Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088452102033420884521020334
1088452102033710884521020337
3088452102033130884521020331

GMDN Terms#

Term, Definition table
TermDefinition
Dental suction systemAn assembly of devices designed to aspirate water, blood, saliva, and tooth debris from the oral cavity by means of suction, to maintain a clear operative site during dental surgical, professional hygiene, and orthodontic procedures. It consists of an electrically-powered suction pump with a control knob and patient contact devices (typically suction handpiece/tip); collection containers, spittoon, tubing, and amalgam separator are also often included.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep dry;AVOID DIRECT SUNLIGHT

Regulatory Flags#

DUNS number
080935429
Device count
250
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10884521189652Monoject1186000444T1186000444T2016-09-24
10884527007110Argyle888816305588881630552016-09-24
20885380173537Curity7267G7267G2019-11-14
20885380173568Curity9024G9024G2019-11-14
20885380174473Curity1806G1806G2019-11-14
20885380174480Curity1903G1903G2019-11-14
20885380174558Curity3968G3968G2019-11-14
20885380174589Dermacea441407G441407G2019-11-14
20885380174596Dermacea441408G441408G2019-11-14
20885380174602Curity6241G6241G2019-11-14
20885380174619Curity6242PG6242PG2019-11-14
20885380174626Curity6318G6318G2019-11-14
20885380174633Curity6939G6939G2019-11-14
20885380174657Curity8043G8043G2019-11-14
20885380174664Curity8044G8044G2019-11-14
20885380174688Curity8046G8046G2019-11-14
20885380174886Curity7605G7605G2019-11-14
00885380173830Curity6241G6241G2020-10-23
00885380173847Curity6242PG6242PG2020-10-23
00885380173878Curity8042G8042G2020-10-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840456202678JMUJMU DENTAL, INCDYN2026-07-06
00840456214602JMUJMU DENTAL, INCDYN2026-07-06
00840456202654JMUJMU DENTAL, INCDYN2026-06-23
00840456202661JMUJMU DENTAL, INCDYN2026-06-23
00840456202685JMUJMU DENTAL, INCDYN2026-06-23
00840456216958JMUJMU DENTAL, INCDYN2026-06-23
00840456216965JMUJMU DENTAL, INCDYN2026-06-23
00840456216972JMUJMU DENTAL, INCDYN2026-06-23
D77162950AS1Dental CityICP, INC.DYN2026-05-27
00840161307118Mr. Thirsty® One-Step - High Volume Evacuator - Large - 1 CountZIRC DENTAL PRODUCTS, INC.DYN2026-04-30
00840161307132Mr. Thirsty® One-Step - High Volume Evacuator - MediumZIRC DENTAL PRODUCTS, INC.DYN2026-04-30
00840161311887Mr. Thirsty® One-Step - High Volume Evacuator - SmallZIRC DENTAL PRODUCTS, INC.DYN2026-04-30
60840161307110Mr. Thirsty® One-Step - Large (with 10mm and 16mm Adaptors) - 50 CountZIRC DENTAL PRODUCTS, INC.DYN2026-04-08
60840161307134Mr. Thirsty® One-Step - Medium (with 10mm and 16mm Adaptors) - 50 CountZIRC DENTAL PRODUCTS, INC.DYN2026-04-08
60840161307158Mr. Thirsty® One-Step - Small (with 10mm and 16mm Adaptors) - 50 CountZIRC DENTAL PRODUCTS, INC.DYN2026-04-08
70840161307117Mr. Thirsty® One-Step - Large (with 10mm and 16mm Adaptors) - 100 CountZIRC DENTAL PRODUCTS, INC.DYN2026-04-08
70840161307131Mr. Thirsty® One-Step - Medium (with 10mm and 16mm Adaptors) - 100 CountZIRC DENTAL PRODUCTS, INC.DYN2026-04-08
70840161307155Mr. Thirsty® One-Step - Small (with 10mm and 16mm Adaptors) - 100 CountZIRC DENTAL PRODUCTS, INC.DYN2026-04-08
00840161307125Mr. Thirsty® One-Step - High Volume Evacuator - Large - 50 CountZIRC DENTAL PRODUCTS, INC.DYN2026-04-08
00840161307149Mr. Thirsty® One-Step - High Volume Evacuator - Medium - 50 CountZIRC DENTAL PRODUCTS, INC.DYN2026-04-08
00840161307156Mr. Thirsty® One-Step - High Volume Evacuator - Small - 50 CountZIRC DENTAL PRODUCTS, INC.DYN2026-04-08
00840161308443Mr. Thirsty® One-Step - High Volume Evacuator - Small - 100 CountZIRC DENTAL PRODUCTS, INC.DYN2026-04-08
00840161309099Mr. Thirsty® One-Step - Variety Pack (with 10mm and 16mm Adaptors) - 30 CountZIRC DENTAL PRODUCTS, INC.DYN2026-04-08
00840161310484Mr. Thirsty® One-Step - Adaptor for Mr. Thirsty® One-Step - 10mm - 1 CountZIRC DENTAL PRODUCTS, INC.DYN2026-04-08
00840161310491Mr. Thirsty® One-Step - Adaptor for Mr. Thirsty® One-Step - 16mm - 1 CountZIRC DENTAL PRODUCTS, INC.DYN2026-04-08
00840161304735Lingua-Fix® - Low-Volume Evacuator - 10 CountZIRC DENTAL PRODUCTS, INC.DYN2026-04-07
00840161304742Lingua-Fix® - Low-Volume Evacuator - 50 CountZIRC DENTAL PRODUCTS, INC.DYN2026-04-07
00840161304766SE Cushion - Saliva Ejector Cushion - 100 CountZIRC DENTAL PRODUCTS, INC.DYN2026-04-07
07615208536706Optragate Dry ControlIVOCLAR VIVADENT AKTIENGESELLSCHAFTDYN2025-12-04
07615208536744Optragate Dry ControlIVOCLAR VIVADENT AKTIENGESELLSCHAFTDYN2025-12-04