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) (10)

Premarket Exempt

No Yes

Clear

SFAM - 00850987007406 Catalog Number : SFAM500 A/B

Device Description : "SFAM 500 A/B 5mm ePTFE Block - 3cm X 7cm"

Device Class : 2

Duns Number: 080380106

Premarket Exempt : No

Product Code : KKY

Prescription Use : Yes

Device Count : 1

SFAM - 00850987007413 Catalog Number : SFAM035

Device Description : "SFAM035 ePTFE Flat Sheet (0.35mm)"

Device Class : 2

Duns Number: 080380106

Premarket Exempt : No

Product Code : KKY

Prescription Use : Yes

Device Count : 1

SFAM - 00850987007420 Catalog Number : SFAM035C

Device Description : "SFAM035C ePTFE Contoured Sheet (0.35mm)"

Device Class : 2

Duns Number: 080380106

Premarket Exempt : No

Product Code : KKY

Prescription Use : Yes

Device Count : 1

SFAM - 00850987007437 Catalog Number : SFAM100

Device Description : "SFAM100 1mm ePFTE (20-40 micron) - 3 cm x 7cm"

Device Class : 2

Duns Number: 080380106

Premarket Exempt : No

Product Code : KKY

Prescription Use : Yes

Device Count : 1

SFAM - 00850987007444 Catalog Number : SFAM1000

Device Description : "SFAM1000 10mm ePTFE Block - 3cm X 6cm"

Device Class : 2

Duns Number: 080380106

Premarket Exempt : No

Product Code : KKY

Prescription Use : Yes

Device Count : 1

SFAM - 00850987007451 Catalog Number : SFAM1001

Device Description : "SFAM1001 10mm ePTFE Block - 6cm X 5cm"

Device Class : 2

Duns Number: 080380106

Premarket Exempt : No

Product Code : KKY

Prescription Use : Yes

Device Count : 1

SFAM - 00850987007468 Catalog Number : SFAM1002

Device Description : "SFAM1002 10mm ePTFE Block - 6cm X 10cm"

Device Class : 2

Duns Number: 080380106

Premarket Exempt : No

Product Code : KKY

Prescription Use : Yes

Device Count : 1

SFAM - 00850987007475 Catalog Number : SFAM101

Device Description : "SFAM101 1mm ePFTE (20-40 micron) - 7 cm x 7cm"

Device Class : 2

Duns Number: 080380106

Premarket Exempt : No

Product Code : KKY

Prescription Use : Yes

Device Count : 1

SFAM - 00850987007482 Catalog Number : SFAM200

Device Description : "SFAM200 2mm ePFTE (20-40 micron) - 3 cm x 7cm"

Device Class : 2

Duns Number: 080380106

Premarket Exempt : No

Product Code : KKY

Prescription Use : Yes

Device Count : 1

SFAM - 00850987007499 Catalog Number : SFAM201

Device Description : "SFAM201 2mm ePFTE (20-40 micron) - 7 cm x 7cm"

Device Class : 2

Duns Number: 080380106

Premarket Exempt : No

Product Code : KKY

Prescription Use : Yes

Device Count : 1

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