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 - 09321502009515 Catalog Number : S50609

Device Description : FREEDOM PROCESSING UNIT, BEIGE

Device Class : 3

Duns Number: 750551194

Premarket Exempt : No

Product Code : MCM

Prescription Use : Yes

Device Count : 1

Nucleus - 09321502009522 Catalog Number : S50621

Device Description : FREEDOM PROCESSING UNIT, BROWN

Device Class : 3

Duns Number: 750551194

Premarket Exempt : No

Product Code : MCM

Prescription Use : Yes

Device Count : 1

Nucleus - 09321502009539 Catalog Number : S50622

Device Description : FREEDOM PROCESSING UNIT, BLACK

Device Class : 3

Duns Number: 750551194

Premarket Exempt : No

Product Code : MCM

Prescription Use : Yes

Device Count : 1

Nucleus - 09321502009546 Catalog Number : S50623

Device Description : FREEDOM PROCESSING UNIT, SILVER

Device Class : 3

Duns Number: 750551194

Premarket Exempt : No

Product Code : MCM

Prescription Use : Yes

Device Count : 1

Nucleus - 09321502009553 Catalog Number : S50778

Device Description : FREEDOM PROCESSING UNIT, PEARL PINK

Device Class : 3

Duns Number: 750551194

Premarket Exempt : No

Product Code : MCM

Prescription Use : Yes

Device Count : 1

Nucleus - 09321502009560 Catalog Number : S50779

Device Description : FREEDOM PROCESSING UNIT, PEARL BLUE

Device Class : 3

Duns Number: 750551194

Premarket Exempt : No

Product Code : MCM

Prescription Use : Yes

Device Count : 1

Nucleus - 09321502009577 Catalog Number : Z60832

Device Description : FREEDOM MONITOR EARPHONES (ME1)

Device Class : 3

Duns Number: 750551194

Premarket Exempt : No

Product Code : MCM

Prescription Use : Yes

Device Count : 1

Nucleus - 09321502009584 Catalog Number : Z60686

Device Description : Cochlear Nucleus Freedom Programming POD

Device Class : 3

Duns Number: 750551194

Premarket Exempt : No

Product Code : MCM

Prescription Use : Yes

Device Count : 1

Nucleus - 09321502010023 Catalog Number : Z126961

Device Description : FREEDOM BABYWORN ACCESSORY PACK

Device Class : 3

Duns Number: 750551194

Premarket Exempt : No

Product Code : MCM

Prescription Use : Yes

Device Count : 1

Nucleus - 09321502010047 Catalog Number : Z126954

Device Description : FREEDOM BABYWORN CABLE BEIGE, 25CM

Device Class : 3

Duns Number: 750551194

Premarket Exempt : No

Product Code : MCM

Prescription Use : Yes

Device Count : 1

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