SURGICAL TECHNOLOGY LABORATORIES INC

Address:1566 Whiting Way,Lugoff,SC,29078,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

Prosthesis, Nose, Internal (FZE) (6) Prosthesis, Chin, Internal (FWP) (4)

Premarket Exempt

No Yes

Clear

Surgiform - 00851988007600 Catalog Number : OFD1-01

Device Description : "OFD1-01 Ofodile Series I Silicone Implants"

Device Class : 2

Duns Number: 080380106

Premarket Exempt : No

Product Code : FZE

Prescription Use : Yes

Device Count : 1

Surgiform - 00851988007617 Catalog Number : OFD1-02

Device Description : "OFD1-02 Ofodile Series I Silicone Implants"

Device Class : 2

Duns Number: 080380106

Premarket Exempt : No

Product Code : FZE

Prescription Use : Yes

Device Count : 1

Surgiform - 00851988007624 Catalog Number : OFD1-03

Device Description : "OFD1-03 Ofodile Series I Silicone Implants"

Device Class : 2

Duns Number: 080380106

Premarket Exempt : No

Product Code : FZE

Prescription Use : Yes

Device Count : 1

Surgiform - 00851988007631 Catalog Number : OFD2-01

Device Description : "OFD2-01 Ofodile Series II Silicone Implants"

Device Class : 2

Duns Number: 080380106

Premarket Exempt : No

Product Code : FZE

Prescription Use : Yes

Device Count : 1

Surgiform - 00851988007648 Catalog Number : OFD2-02

Device Description : "OFD2-02 Ofodile Series II Silicone Implants"

Device Class : 2

Duns Number: 080380106

Premarket Exempt : No

Product Code : FZE

Prescription Use : Yes

Device Count : 1

Surgiform - 00851988007655 Catalog Number : OFD2-03

Device Description : "OFD2-03 Ofodile Series II Silicone Implants"

Device Class : 2

Duns Number: 080380106

Premarket Exempt : No

Product Code : FZE

Prescription Use : Yes

Device Count : 1

Surgiform - 00851988007662 Catalog Number : SC-01

Device Description : "SC-01 Standard Chin Silicone Implants"

Device Class : 2

Duns Number: 080380106

Premarket Exempt : No

Product Code : FWP

Prescription Use : Yes

Device Count : 1

Surgiform - 00851988007679 Catalog Number : SC-02

Device Description : "SC-02 Standard Chin Silicone Implants"

Device Class : 2

Duns Number: 080380106

Premarket Exempt : No

Product Code : FWP

Prescription Use : Yes

Device Count : 1

Surgiform - 00851988007686 Catalog Number : SC-03

Device Description : "SC-03 Standard Chin Silicone Implants"

Device Class : 2

Duns Number: 080380106

Premarket Exempt : No

Product Code : FWP

Prescription Use : Yes

Device Count : 1

Surgiform - 00851988007693 Catalog Number : SC-04

Device Description : "SC-04 Standard Chin Silicone Implants"

Device Class : 2

Duns Number: 080380106

Premarket Exempt : No

Product Code : FWP

Prescription Use : Yes

Device Count : 1

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