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

Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction (KKY) (5) Prosthesis, Nose, Internal (FZE) (3) Tubing, Noninvasive (GAZ) (1)

Premarket Exempt

No Yes

Clear

SFAM - 00854804007006 Catalog Number : SFAM603

Device Description : SFAM603 ePTFE Block 1.5cm x 6cm

Device Class : 2

Duns Number: 080380106

Premarket Exempt : No

Product Code : KKY

Prescription Use : Yes

Device Count : 1

SFAM - 00854804007013 Catalog Number : SFAM803

Device Description : SFAM803 ePTFE Block 1.5cm X 6cm

Device Class : 2

Duns Number: 080380106

Premarket Exempt : No

Product Code : KKY

Prescription Use : Yes

Device Count : 1

SFAM - 00854804007020 Catalog Number : SFAM1003

Device Description : SFAM1003 ePTFE Block 1.5cm x 6cm

Device Class : 2

Duns Number: 080380106

Premarket Exempt : No

Product Code : KKY

Prescription Use : Yes

Device Count : 1

SFAM - 00854804007037 Catalog Number : SFAM503

Device Description : SFAM503 ePTFE Block - 1.5cm x 6cm

Device Class : 2

Duns Number: 080380106

Premarket Exempt : No

Product Code : KKY

Prescription Use : Yes

Device Count : 1

Saf-T-Vac Filter Adaptor - 00854804007044 Catalog Number :

Device Description : 1/4 inch to 7/8 inch adaptor for the Saf-T-Vac Smoke and Fluid Evacuator

Device Class : 2

Duns Number: 080380106

Premarket Exempt : Yes

Product Code : GAZ

Prescription Use : Yes

Device Count : 1

SFAM - 00854804007051 Catalog Number :

Device Description : 6mm ePTFE Block - 1.5cm x 6.2cm

Device Class : 2

Duns Number: 080380106

Premarket Exempt : No

Product Code : KKY

Prescription Use : Yes

Device Count : 1

PureForm - 00854804007068 Catalog Number : 6PN01*

Device Description : "6PN01* PureForm Para-Nasal - Large Left"

Device Class : 2

Duns Number: 080380106

Premarket Exempt : No

Product Code : FZE

Prescription Use : Yes

Device Count : 1

PureForm - 00854804007075 Catalog Number : 4PN01*

Device Description : "4PN01* PureForm Para-Nasal - Small Left"

Device Class : 2

Duns Number: 080380106

Premarket Exempt : No

Product Code : FZE

Prescription Use : Yes

Device Count : 1

PureForm - 00854804007082 Catalog Number : 5PN01*

Device Description : "5PN01* PureForm Para-Nasal - Medium Left"

Device Class : 2

Duns Number: 080380106

Premarket Exempt : No

Product Code : FZE

Prescription Use : Yes

Device Count : 1

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