FDA.reportPublic FDA data

KICo Tetrous Instruments Tray

Primary DI
B432MOTRA06700
Brand
KICo Tetrous Instruments Tray
Company
KICO KNEE INNOVATION COMPANY PTY LIMITED
Model
MO-TRA-0670
Device description
MO-TRA-0670 KICo Tetrous Instruments Tray
Published
2024-04-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
OJHOrthopedic Tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OJHOrthopedic TrayGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B432MOTRA06700PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Instrument tray, reusableA container intended to provide a suitable platform for placing/containing many medical/surgical/dental instruments and related items for use during a clinical procedure; it might, in addition, be used during, but not dedicated to, reprocessing/sterilization procedures. It is a receptacle in one of a variety of designs, typically with moulded positions for placing the instruments; it might include a lid and/or removable identification tags. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
757918953
Device count
1
Premarket exempt
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810180350020ARVIS ®IN-280002025-11-17
00810180350037ARVIS ®IN-280102025-11-17
00810180350044ARVIS ®IN-280202025-11-17
00810180350051ARVIS ®IN-280502025-11-17
00810180350068ARVIS ®IN-280702025-11-17
00810180350099ARVIS ®IN-281002025-11-17
00810180350105ARVIS ®IN-281202025-11-17
00810180350112ARVIS ®IN-281302025-11-17
00810180350167ARVIS ®IN-281502025-11-17
00810180350174ARVIS ®IN-281602025-11-17
00810180350785ARVIS ®IN-290002025-11-17
00810180350792ARVIS ®IN-291002025-11-17
00810180350808ARVIS ®IN-290022025-11-17
00810180350815ARVIS ®IN-290052025-11-17
00810180350822ARVIS ®IN-290032025-11-17
00810180350839ARVIS ®IN-290072025-11-17
00810180350846ARVIS ®IN-290082025-11-17
00810180350853ARVIS ®IN-290182025-11-17
00810180350860ARVIS ®IN-290302025-11-17
00810180350877ARVIS ®IN-290012025-11-17

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