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

Elastomer, Silicone Block (MIB) (8) Implant, Malar (LZK) (2)

Premarket Exempt

No Yes

Clear

Surgiform - 00851988007808 Catalog Number : TM-03

Device Description : "TM-03 Trapezoidal Malar Silicone Implants"

Device Class : 2

Duns Number: 080380106

Premarket Exempt : No

Product Code : LZK

Prescription Use : Yes

Device Count : 1

Surgiform - 00851988007815 Catalog Number : TM-04

Device Description : "TM-04 Trapezoidal Malar Silicone Implants"

Device Class : 2

Duns Number: 080380106

Premarket Exempt : No

Product Code : LZK

Prescription Use : Yes

Device Count : 1

Surgiform - 00851988007822 Catalog Number : SB-01

Device Description : "SB-01 Silicone Block - Size One - Med Duro - Clear Silicone Implants"

Device Class : 2

Duns Number: 080380106

Premarket Exempt : No

Product Code : MIB

Prescription Use : Yes

Device Count : 1

Surgiform - 00851988007839 Catalog Number : SB-1SF

Device Description : "SB-1SF Silicone Block - Size One - Soft -Flesh Tone Silicone Implants"

Device Class : 2

Duns Number: 080380106

Premarket Exempt : No

Product Code : MIB

Prescription Use : Yes

Device Count : 1

Surgiform - 00851988007846 Catalog Number : SB-1SC

Device Description : "SB-1SC Silicone Block - Size One - Soft -Clear Silicone Implants"

Device Class : 2

Duns Number: 080380106

Premarket Exempt : No

Product Code : MIB

Prescription Use : Yes

Device Count : 1

Surgiform - 00851988007853 Catalog Number : SB-1MF

Device Description : "SB-1MF Silicone Block - Size One - Med Duro -Flesh Tone Silicone Implants"

Device Class : 2

Duns Number: 080380106

Premarket Exempt : No

Product Code : MIB

Prescription Use : Yes

Device Count : 1

Surgiform - 00851988007860 Catalog Number : SB-02

Device Description : "SB-02 Silicone Block - Size Two - Med Duro - Clear"

Device Class : 2

Duns Number: 080380106

Premarket Exempt : No

Product Code : MIB

Prescription Use : Yes

Device Count : 1

Surgiform - 00851988007877 Catalog Number : SB-2SC

Device Description : "SB-2SC Silicone Block - Size Two - Soft -Clear"

Device Class : 2

Duns Number: 080380106

Premarket Exempt : No

Product Code : MIB

Prescription Use : Yes

Device Count : 1

Surgiform - 00851988007884 Catalog Number : SB-2SF

Device Description : "SB-2SF Silicone Block - Size Two - Soft -Flesh Tone Silicone Implants"

Device Class : 2

Duns Number: 080380106

Premarket Exempt : No

Product Code : MIB

Prescription Use : Yes

Device Count : 1

Surgiform - 00851988007891 Catalog Number : SB-2MF

Device Description : "SB-2MF Silicone Block - Size Two - Med Duro -Flesh Tone"

Device Class : 2

Duns Number: 080380106

Premarket Exempt : No

Product Code : MIB

Prescription Use : Yes

Device Count : 1

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