MERZ NORTH AMERICA, INC.

Address:13900 W. Grandview Parkway,Sturtevant,WI,53177,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

Implant, Dermal, For Aesthetic Use (LMH) (5) Transparent Patch For Use In Treatment Of Tattoos (PKO) (3) Agent, Bulking, Injectable For Gastro-Urology Use (LNM) (1) Implant, Dermal, For Aesthetic Use In The Hands (PKY) (1) System, Vocal Cord Medialization (MIX) (1)

Premarket Exempt

Clear

DeScribe Transparent PFD Patch - 00186295000342 Catalog Number :

Device Description : Individually packaged DeScribe PFD Patch (each)Contains 5 DeScribe PFD Patches.

Device Class : 2

Duns Number: 028147846

Premarket Exempt : No

Product Code : PKO

Prescription Use : Yes

Device Count : 1

DeScribe Transparent PFD Patch - 00186295000359 Catalog Number :

Device Description : Individually packaged DeScribe PFD Patch (each)

Device Class :

Duns Number: 028147846

Premarket Exempt : No

Product Code : PKO

Prescription Use : Yes

Device Count : 1

DeScribe Transparent PFD Patch - 00186295000366 Catalog Number :

Device Description : Individually packaged DeScribe PFD Patch (each). Contains 2 Describe PFD Patches.

Device Class : 2

Duns Number: 028147846

Premarket Exempt : No

Product Code : PKO

Prescription Use : Yes

Device Count : 1

Coaptite - 08714729804796 Catalog Number : M0068903000

Device Description : The Coaptite Injectable Implant is a permanently implanted device used to treat

Device Class : 3

Duns Number: 028147846

Premarket Exempt : No

Product Code : LNM

Prescription Use : Yes

Device Count : 1

Prolaryn Plus Injectable Implant - M2138044M0K55 Catalog Number :

Device Description : Prolaryn Plus is a water based injectable gel implant used to treat vocal fold i

Device Class : 2

Duns Number: 028147846

Premarket Exempt : No

Product Code : MIX

Prescription Use : Yes

Device Count : 1

Radiesse (+) Lidocaine1.5cc Injectable Implant - M2138063M0K15 Catalog Number :

Device Description : Radiesse (+) Lidocaine 1.5cc Injectable Implant is a volumizing filler with inte

Device Class : 3

Duns Number: 028147846

Premarket Exempt : No

Product Code : LMH

Prescription Use : Yes

Device Count : 1

Radiesse (+) Lidocaine - M2138063M0K25 Catalog Number :

Device Description : Radiesse (+) Lidocaine 1.5cc Injectable Implant is a volumizing filler with inte

Device Class :

Duns Number: 028147846

Premarket Exempt : No

Product Code : LMH

Prescription Use : Yes

Device Count : 2

Radiesse (+) Lidocaine 0.8cc Injectable Implant - M2138067M0K15 Catalog Number :

Device Description : Radiesse (+) Lidocaine Injectable Implant is a volumizing filler with lidocaine

Device Class : 3

Duns Number: 028147846

Premarket Exempt : No

Product Code : LMH

Prescription Use : Yes

Device Count : 1

Radiesse Moderate Fill 0.8cc - M2138069M0K15 Catalog Number :

Device Description : Radiesse Injectable Implant is a volumizing filler indicated for subdermal impla

Device Class : 3

Duns Number: 028147846

Premarket Exempt : No

Product Code : LMH

Prescription Use : Yes

Device Count : 1

Radiesse Volume Advantage 1.5cc - M2138071C0K15 Catalog Number :

Device Description : Radiesse Injectable Implant is a volumizing filler indicated for subdermal impla

Device Class : 3

Duns Number: 028147846

Premarket Exempt : No

Product Code : PKY, LMH

Prescription Use : Yes

Device Count : 1

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