FCL HEALTH SOLUTIONS LTD

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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

Acid, Hyaluronic, Intraarticular (MOZ) (7) Implant, Dermal, For Aesthetic Use (LMH) (1) Implant, Dermal, For Aesthetic Use In The Hands (PKY) (1)

Premarket Exempt

Clear

Supartz - 05060432190019 Catalog Number :

Device Class :

Duns Number: 219706976

Premarket Exempt : No

Product Code : MOZ

Prescription Use : Yes

Device Count : 1

Monovisc - 05060432190026 Catalog Number :

Device Class : 3

Duns Number: 219706976

Premarket Exempt : No

Product Code : MOZ

Prescription Use : Yes

Device Count : 1

Radiesse - 05060432190033 Catalog Number :

Device Class : 3

Duns Number: 219706976

Premarket Exempt : No

Product Code : PKY, LMH

Prescription Use : Yes

Device Count : 1

SYNVISC ONE - 15060432190009 Catalog Number :

Device Description : Acid, Hyaluronic, Intraarticular

Device Class : 3

Duns Number: 219706976

Premarket Exempt : No

Product Code : MOZ

Prescription Use : Yes

Device Count : 1

SYNVISC - 25060432190006 Catalog Number :

Device Description : injectable (hyaluronic acid, intra-articular)

Device Class :

Duns Number: 219706976

Premarket Exempt : No

Product Code : MOZ

Prescription Use : Yes

Device Count : 3

HYALGAN - 35060432190003 Catalog Number :

Device Description : injectable (hyaluronic acid, intra-articular)

Device Class : 3

Duns Number: 219706976

Premarket Exempt : No

Product Code : MOZ

Prescription Use : Yes

Device Count : 1

Euflexxa - 45060432190000 Catalog Number :

Device Class :

Duns Number: 219706976

Premarket Exempt : No

Product Code : MOZ

Prescription Use : Yes

Device Count : 3

Orthovisc - 75060432190001 Catalog Number :

Device Class : 3

Duns Number: 219706976

Premarket Exempt : No

Product Code : MOZ

Prescription Use : Yes

Device Count : 1

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