FDA.reportPublic FDA data

KICo Probe

Primary DI
B432MOPRB0651B0
Brand
KICo Probe
Company
KICO KNEE INNOVATION COMPANY PTY LIMITED
Model
MO-PRB-0651-B
Device description
Probe
Published
2024-12-20
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
HXBProbe

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HXBProbeOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B432MOPRB0651B0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Abdominal/ENT/orthopaedic surgical probe, reusableA slender, rod-like, hand-held manual surgical instrument intended to be used to explore cavities, wounds or fistulas during abdominal, ENT, and/or orthopaedic surgical interventions; it does not include stereotactic devices and is not dedicated to endoscopy. It may have a blunt bulbous, paddle-like, or pointed tip, may be single- or double-ended, and the shaft may be straight, bent or hooked. It is made of rigid or flexible metallic and/or synthetic polymer material. 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
Lot or batch
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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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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07640221373045PERLA ® TLSpineArt SAHXB2026-05-07
08800017271095ProbeCorentec Co., LtdHXB2026-04-10
10649111181665Sklar InstrumentsSKLAR CORPORATIONHXB2025-05-29
07640177820631Neo Medical Pedicle Screw SystemNeo Medical SAHXB2023-01-26
07898506815241QuinelatoSchobell Industrial LtdaHXB2023-01-09
07899798204461SchobellSchobell Industrial LtdaHXB2022-12-16
G079C5020010040Golden Isles Pedicle Screw SystemIntelivation, LLCHXB2022-10-26
10649111296673SklarSKLAR CORPORATIONHXB2019-03-19
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