SOFREGEN MEDICAL INC.

SOFREGEN MEDICAL INC.

Address:175 Crossing Boulevard,Framingham,MA,01702,US

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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

Mesh, Surgical, Absorbable, Plastic And Reconstructive Surgery (OXF) (5) System, Vocal Cord Medialization (MIX) (5)

Premarket Exempt

No

Clear

SERI - B6119467707 Catalog Number :

Device Description : SERI Surgical Scaffold 15cm x 25cm

Device Class : 2

Duns Number: 079710838

Premarket Exempt : No

Product Code : OXF

Prescription Use : Yes

Device Count : 1

SERI - B6119467808 Catalog Number :

Device Description : SERI Surgical Scaffold 20cm x 30cm

Device Class : 2

Duns Number: 079710838

Premarket Exempt : No

Product Code : OXF

Prescription Use : Yes

Device Count : 1

SERI - B6119467909 Catalog Number :

Device Description : SERI Surgical Scaffold 5cm x 15cm

Device Class : 2

Duns Number: 079710838

Premarket Exempt : No

Product Code : OXF

Prescription Use : Yes

Device Count : 1

SERI - B6119468001 Catalog Number :

Device Description : SERI Surgical Scaffold 10cm x 25cm

Device Class : 2

Duns Number: 079710838

Premarket Exempt : No

Product Code : OXF

Prescription Use : Yes

Device Count : 1

SERI Contour - B611955121 Catalog Number : 95512

Device Description : SERI Contour Surgical Scaffold 10cm x 25cm

Device Class : 2

Duns Number: 079710838

Premarket Exempt : No

Product Code : OXF

Prescription Use : Yes

Device Count : 1

SilkVoice - B611SV1001 Catalog Number : SV1001

Device Description : SilkVoice Injectable Implant, 1cc Syringe, 2 needles

Device Class : 2

Duns Number: 079710838

Premarket Exempt : No

Product Code : MIX

Prescription Use : Yes

Device Count : 1

SilkVoice - B611SV10011 Catalog Number : SV1001

Device Description : SilkVoice Injectable Implant, 1cc Syringe, 2 needles

Device Class : 2

Duns Number: 079710838

Premarket Exempt : No

Product Code : MIX

Prescription Use : Yes

Device Count : 1

SilkVoice - B611SV1002 Catalog Number : SV1002

Device Description : SilkVoice Injectable Implant, 1cc Syringe, 2 each

Device Class : 2

Duns Number: 079710838

Premarket Exempt : No

Product Code : MIX

Prescription Use : Yes

Device Count : 1

SilkVoice - B611SV10021 Catalog Number : SV1002

Device Description : SilkVoice Injectable Implant, 1cc Syringe, 2 each

Device Class : 2

Duns Number: 079710838

Premarket Exempt : No

Product Code : MIX

Prescription Use : Yes

Device Count : 1

SilkVoice - B611SV2001 Catalog Number : SV2001

Device Description : SilkVoice catheter 70cm

Device Class : 2

Duns Number: 079710838

Premarket Exempt : No

Product Code : MIX

Prescription Use : Yes

Device Count : 1

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