Anika Therapeutics, Inc.

Address:32 Wiggins Ave,Bedford,MA,01730,US

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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) (2) Aid, Surgical, Viscoelastic (LZP) (1) Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material) (KHJ) (1)

Premarket Exempt

Clear

Epifilm Otologic - 08033549791063 Catalog Number : 1417000

Device Description : Epifilm Otologic Lamina is intended for use as an implant material to aid in sur Epifilm Otologic Lamina is intended for use as an implant material to aid in surgical repairs and as an adjunct to aid in the natural healing process in various otologic procedures.

Device Class : 2

Duns Number: 807613393

Premarket Exempt : No

Product Code : KHJ

Prescription Use : No

Device Count : 1

Orthovisc - 10886705023110 Catalog Number :

Device Description : 2 mL, 15 mg/mL High Molecular weight Hyaluronan

Device Class : 3

Duns Number: 807613393

Premarket Exempt : No

Product Code : MOZ

Prescription Use : Yes

Device Count : 1

Monovisc - 10886705025183 Catalog Number :

Device Description : 4 mL, 22 mg/mL High Molecular Weight Hyaluronan

Device Class : 3

Duns Number: 807613393

Premarket Exempt : No

Product Code : MOZ

Prescription Use : Yes

Device Count : 1

NuVisc - 30886158020067 Catalog Number :

Device Description : 0.8 ml, 1.2% OVD Sodium Hyaluronate

Device Class : 3

Duns Number: 807613393

Premarket Exempt : No

Product Code : LZP

Prescription Use : Yes

Device Count : 1

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