CARTIHEAL (2009) LTD

Address:17 Atir Yeda Street,Kfar Saba Central,IL

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Instruments Designed For Press-Fit Osteochondral Implants (QBO) (6) Implant, Resorbable, For Articular Osteochondral Repair (QRU) (4)

Premarket Exempt

No Yes

Clear

Agili-C - 07290019087007 Catalog Number :

Device Description : Agili-C Implant Diameter 7.5mm Length 10mm

Device Class :

Duns Number: 533214388

Premarket Exempt : No

Product Code : QRU

Prescription Use : Yes

Device Count : 1

Agili-C - 07290019087014 Catalog Number :

Device Description : Agili-C Implant Diameter 10mm, Length 10mm

Device Class :

Duns Number: 533214388

Premarket Exempt : No

Product Code : QRU

Prescription Use : Yes

Device Count : 1

Agili-C - 07290019087021 Catalog Number :

Device Description : Agili-C Implant Diameter 12.5mm, Length 10mm

Device Class :

Duns Number: 533214388

Premarket Exempt : No

Product Code : QRU

Prescription Use : Yes

Device Count : 1

Agili-C - 07290019087038 Catalog Number :

Device Description : Agili-C Implant Diameter 15mm , Length 10mm

Device Class :

Duns Number: 533214388

Premarket Exempt : No

Product Code : QRU

Prescription Use : Yes

Device Count : 1

Agili-C Mini Disposable Toolset - 07290019087045 Catalog Number : MINI-DS

Device Description : Agili-C Mini Disposable Toolset

Device Class : 2

Duns Number: 533214388

Premarket Exempt : Yes

Product Code : QBO

Prescription Use : Yes

Device Count : 1

Agili-C Mini Disposable Toolset - 07290019087052 Catalog Number :

Device Description : Agili-C Mini Disposable Toolset Diameter 10mm

Device Class : 2

Duns Number: 533214388

Premarket Exempt : Yes

Product Code : QBO

Prescription Use : Yes

Device Count : 1

Agili-C Mini Disposable Toolset - 07290019087069 Catalog Number :

Device Description : Agili-C Mini Disposable Toolset Diameter 12.5mm

Device Class : 2

Duns Number: 533214388

Premarket Exempt : Yes

Product Code : QBO

Prescription Use : Yes

Device Count : 1

Agili-C Mini Disposable Toolset - 07290019087076 Catalog Number :

Device Description : Agili-C Mini Disposable Toolset Diameter 15mm

Device Class : 2

Duns Number: 533214388

Premarket Exempt : Yes

Product Code : QBO

Prescription Use : Yes

Device Count : 1

Agili-C Sterilization Case - 07290019087083 Catalog Number :

Device Description : Agili-C Sterilization Case

Device Class : 2

Duns Number: 533214388

Premarket Exempt : Yes

Product Code : QBO

Prescription Use : Yes

Device Count : 1

Agili-C Cartilage Cutter - 07290019087090 Catalog Number :

Device Description : Agili-C Cartilage Cutter for Diameter 7.5mm to 12.5mm

Device Class : 2

Duns Number: 533214388

Premarket Exempt : Yes

Product Code : QBO

Prescription Use : Yes

Device Count : 1

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