FDA.reportPublic FDA data

Gynex

Primary DI
GYNXD82010
Brand
Gynex
Company
GYNEX CORPORATION
Model
D82-01
Published
2023-12-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
IRQUnit, Heating, Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IRQUnit, Heating, PoweredPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
GYNXD82010PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Gel warmerA portable, mains electricity (AC-powered) device intended to be used to prewarm gels (e.g., ultrasonic coupling gels, vaginal exploratory gels) prior to patient application. It is typically a tabletop device that includes a recess or a well for placement of a gel container, a heating element, a thermostat, and operating controls.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
012997685
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
GYNX32500Gynex32502023-12-13
GYNX32550Gynex32552023-12-13
GYNX80091Gynex80092023-12-19
GYNX80241Gynex80242023-12-19
GYNX80721Gynex80722023-12-19
GYNX81001Gynex81002023-12-19
GYNX81031Gynex81032023-12-19
GYNX82001Gynex82002023-12-19
GYNX292001Gynex29-2002023-12-26
GYNX293001Gynex29-3002023-12-26
GYNX298501Gynex29-8502023-12-26
GYNX31301Gynex31302023-12-26
GYNX31351Gynex31352023-12-26
GYNX32071Gynex32052023-12-26
GYNX16000Gynex16002023-12-26
GYNX291000Gynex29-1002023-12-26
GYNX292000Gynex29-3002023-12-26
GYNX293500Gynex29-3502023-12-26
GYNX295500Gynex29-5502023-12-26
GYNX297000Gynex29-7002023-12-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07898966442933IbramedIbramed Industria Brasileira de Equipamentos Medicos EirIRQ2025-02-25
07898966442964IbramedIbramed Industria Brasileira de Equipamentos Medicos EirIRQ2025-02-25
00092237626009HydraThermDrive Devilbiss HealthcareIRQ2024-05-14
00092237626016HydraThermDrive Devilbiss HealthcareIRQ2024-05-14
00092237625545HydraThermDrive Devilbiss HealthcareIRQ2024-03-06
00092237625552HydraThermDrive Devilbiss HealthcareIRQ2024-03-06
00092237625569HydraThermDrive Devilbiss HealthcareIRQ2024-03-06
00092237625576HydraThermDrive Devilbiss HealthcareIRQ2024-03-06
00092237625583HydraThermDrive Devilbiss HealthcareIRQ2024-03-06
00092237625590HydraThermDrive Devilbiss HealthcareIRQ2024-03-06
00092237625606HydraThermDrive Devilbiss HealthcareIRQ2024-03-06
00092237625613HydraThermDrive Devilbiss HealthcareIRQ2024-03-06
00092237625620HydraThermDrive Devilbiss HealthcareIRQ2024-03-06
00092237625637HydraThermDrive Devilbiss HealthcareIRQ2024-03-06
00092237625644HydraThermDrive Devilbiss HealthcareIRQ2024-03-06
00092237625651HydraThermDrive Devilbiss HealthcareIRQ2024-03-06
00092237625668HydraThermDrive Devilbiss HealthcareIRQ2024-03-06
00092237625675HydraThermDrive Devilbiss HealthcareIRQ2024-03-06
00092237625460HydraThermDrive Devilbiss HealthcareIRQ2024-03-05
00092237625477HydraThermDrive Devilbiss HealthcareIRQ2024-03-05
00092237625484HydraThermDrive Devilbiss HealthcareIRQ2024-03-05
00092237625491HydraThermDrive Devilbiss HealthcareIRQ2024-03-05
00092237625507HydraThermDrive Devilbiss HealthcareIRQ2024-03-05
00092237625514HydraThermDrive Devilbiss HealthcareIRQ2024-03-05
00092237625521HydraThermDrive Devilbiss HealthcareIRQ2024-03-05
00092237625538HydraThermDrive Devilbiss HealthcareIRQ2024-03-05
00092237625439HydraThermDrive Devilbiss HealthcareIRQ2024-03-01
00092237625354HydraThermDrive Devilbiss HealthcareIRQ2024-02-29
00092237625361HydraThermDrive Devilbiss HealthcareIRQ2024-02-29
00092237625378HydraThermDrive Devilbiss HealthcareIRQ2024-02-29