COCHLEAR LIMITED

Address:14 MARS ROAD,LANE COVE New South Wales,AU

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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

IMPLANT, COCHLEAR (MCM) (10)

Premarket Exempt

No Yes

Clear

Nucleus - 09321502002448 Catalog Number : Z43102

Device Description : CLINICAL PROGRAMMING SYSTEM

Device Class : 3

Duns Number: 750551194

Premarket Exempt : No

Product Code : MCM

Prescription Use : Yes

Device Count : 1

Nucleus - 09321502002493 Catalog Number : Z33011

Device Description : Cochlear Nucleus BTE Template

Device Class : 3

Duns Number: 750551194

Premarket Exempt : No

Product Code : MCM

Prescription Use : Yes

Device Count : 1

Nucleus - 09321502002776 Catalog Number : Z50100

Device Description : CI24RE Series Non-Magnetic Plug

Device Class : 3

Duns Number: 750551194

Premarket Exempt : No

Product Code : MCM

Prescription Use : Yes

Device Count : 1

Nucleus - 09321502002783 Catalog Number : Z50101

Device Description : CI24RE Series Sterile Replacement Magnet

Device Class : 3

Duns Number: 750551194

Premarket Exempt : No

Product Code : MCM

Prescription Use : Yes

Device Count : 1

Nucleus - 09321502002790 Catalog Number : Z60006

Device Description : Cochlear Nucleus Depth Gauge (Straight)

Device Class : 3

Duns Number: 750551194

Premarket Exempt : No

Product Code : MCM

Prescription Use : Yes

Device Count : 1

Nucleus - 09321502003216 Catalog Number : Z99012

Device Description : CI 11 11 2M

Device Class : 3

Duns Number: 750551194

Premarket Exempt : No

Product Code : MCM

Prescription Use : Yes

Device Count : 1

Nucleus - 09321502006422 Catalog Number : Z42038

Device Description : SELF TEST CABLE PPS

Device Class : 3

Duns Number: 750551194

Premarket Exempt : No

Product Code : MCM

Prescription Use : Yes

Device Count : 1

Nucleus - 09321502006637 Catalog Number : Z60033

Device Description : CRYSTAL INTEGRITY TEST SYSTEM

Device Class : 3

Duns Number: 750551194

Premarket Exempt : No

Product Code : MCM

Prescription Use : Yes

Device Count : 1

Nucleus - 09321502006842 Catalog Number : Z22502

Device Description : Signal Check

Device Class : 3

Duns Number: 750551194

Premarket Exempt : No

Product Code : MCM

Prescription Use : Yes

Device Count : 1

Nucleus - 09321502006910 Catalog Number : Z33012

Device Description : Cochlear Nucleus Spacer for Intraoperative Testing

Device Class : 3

Duns Number: 750551194

Premarket Exempt : No

Product Code : MCM

Prescription Use : Yes

Device Count : 1

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