FDA.reportPublic FDA data

Inion® Universal instruments

Primary DI
06438408000331
Brand
Inion® Universal instruments
Company
Inion Oy
Model
1
Catalog number
ACC-9801
Device description
Inion Thermo (water bath 230 V + EU plug)
Published
2020-05-08
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
06438408000331PrimaryGS10
M224ACC98019SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06438408000331064384080003316438408000331

Regulatory Flags#

DUNS number
367994657
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06438408012815Inion CompressOn™ / Inion FreedomScrew™ Instrument1IFS-90672026-08-07
06438408012822Inion CompressOn™ / Inion FreedomScrew™ Instrument1IFS-90682026-08-07
06438408012839Inion CompressOn™ Instrument1IFS-90692026-08-07
06438408012587Inion® Universal instruments2INS-90912026-05-11
06438408012037Inion Hexalon instrument2INS-92002026-05-06
06438408002397Inion Hexalon™ ACL/PCL Screw1ACL-41132022-08-26
06438408002403Inion Hexalon™ ACL/PCL Screw1ACL-41142022-08-26
06438408002410Inion Hexalon™ ACL/PCL Screw1ACL-41152022-08-26
06438408002427Inion Hexalon™ ACL/PCL Screw1ACL-41012022-08-26
06438408002434Inion Hexalon™ ACL/PCL Screw1ACL-41022022-08-26
06438408002441Inion Hexalon™ ACL/PCL Screw1ACL-41032022-08-26
06438408002458Inion Hexalon™ ACL/PCL Screw1ACL-41042022-08-26
06438408002465Inion Hexalon™ ACL/PCL Screw1ACL-41052022-08-26
06438408002472Inion Hexalon™ ACL/PCL Screw1ACL-41062022-08-26
06438408002489Inion Hexalon™ ACL/PCL Screw1ACL-41072022-08-26
06438408002496Inion Hexalon™ ACL/PCL Screw1ACL-41082022-08-26
06438408002502Inion Hexalon™ ACL/PCL Screw1ACL-41092022-08-26
06438408002519Inion Hexalon™ ACL/PCL Screw1ACL-41122022-08-26
06438408012181Inion S-1™1SPN-50042023-12-19
06438408012198Inion S-1™1SPN-50052023-12-19

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