COCHLEAR LIMITED

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 - 09321502000505 Catalog Number : Z60211

Device Description : PROGRAMMING CABLE PPS ESPRIT 3G

Device Class : 3

Duns Number: 750551194

Premarket Exempt : No

Product Code : MCM

Prescription Use : Yes

Device Count : 1

Nucleus - 09321502001953 Catalog Number : Z42230

Device Description : PLUG PACK 220/240V (NON USA)

Device Class : 3

Duns Number: 750551194

Premarket Exempt : No

Product Code : MCM

Prescription Use : Yes

Device Count : 1

Nucleus - 09321502002257 Catalog Number : Z30090

Device Description : Cochlear Nucleus CI24RE Series Electrode Claw (Straight)

Device Class : 3

Duns Number: 750551194

Premarket Exempt : No

Product Code : MCM

Prescription Use : Yes

Device Count : 1

Nucleus - 09321502002271 Catalog Number : Z33020

Device Description : Cochlear Nucleus CI24RE Series Non-Sterile Silicone Implant Template x 5

Device Class :

Duns Number: 750551194

Premarket Exempt : No

Product Code : MCM

Prescription Use : Yes

Device Count : 5

Nucleus - 09321502002288 Catalog Number : Z33021

Device Description : Cochlear Nucleus Contour Electrode Claw

Device Class : 3

Duns Number: 750551194

Premarket Exempt : No

Product Code : MCM

Prescription Use : Yes

Device Count : 1

Nucleus - 09321502002301 Catalog Number : Z42001

Device Description : PORTABLE PROGRAMMING SYSTEM

Device Class : 3

Duns Number: 750551194

Premarket Exempt : No

Product Code : MCM

Prescription Use : Yes

Device Count : 1

Nucleus - 09321502002318 Catalog Number : Z43002

Device Description : COCHLEAR IMPLANT, MODEL CI24M

Device Class : 3

Duns Number: 750551194

Premarket Exempt : No

Product Code : MCM

Prescription Use : Yes

Device Count : 1

Nucleus - 09321502002325 Catalog Number : Z43004

Device Description : ABI 24M

Device Class : 3

Duns Number: 750551194

Premarket Exempt : No

Product Code : MCM

Prescription Use : Yes

Device Count : 1

Nucleus - 09321502002332 Catalog Number : Z43006

Device Description : COCHLEAR IMPLANT, CI24R(ST)

Device Class : 3

Duns Number: 750551194

Premarket Exempt : No

Product Code : MCM

Prescription Use : Yes

Device Count : 1

Nucleus - 09321502002349 Catalog Number : Z43007

Device Description : COCHLEAR IMPLANT,CI24R (CS)

Device Class : 3

Duns Number: 750551194

Premarket Exempt : No

Product Code : MCM

Prescription Use : Yes

Device Count : 1

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