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 - 00850987007505 Catalog Number : SFAM301

Device Description : "SFAM301 3mm 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 - 00850987007512 Catalog Number : SFAM302

Device Description : "SFAM302 3mm 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 - 00850987007529 Catalog Number : SFAM500

Device Description : "SFAM500 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 - 00850987007536 Catalog Number : SFAM501

Device Description : "SFAM501 5mm ePTFE Block - 5cm X 7cm"

Device Class : 2

Duns Number: 080380106

Premarket Exempt : No

Product Code : KKY

Prescription Use : Yes

Device Count : 1

SFAM - 00850987007543 Catalog Number : SFAM502

Device Description : "SFAM502 5mm ePTFE Block Bulk- 6cm x 10cm"

Device Class : 2

Duns Number: 080380106

Premarket Exempt : No

Product Code : KKY

Prescription Use : Yes

Device Count : 1

SFAM - 00850987007550 Catalog Number : SFAM600

Device Description : "SFAM600 6mm ePTFE Block - 3cm X 6cm"

Device Class : 2

Duns Number: 080380106

Premarket Exempt : No

Product Code : KKY

Prescription Use : Yes

Device Count : 1

SFAM - 00850987007567 Catalog Number : SFAM601

Device Description : "SFAM601 6mm ePTFE Block - 5cm X 6cm"

Device Class : 2

Duns Number: 080380106

Premarket Exempt : No

Product Code : KKY

Prescription Use : Yes

Device Count : 1

SFAM - 00850987007574 Catalog Number : SFAM800

Device Description : SFAM800 8mm ePTFE Block - 3cm X 7cm

Device Class : 2

Duns Number: 080380106

Premarket Exempt : No

Product Code : KKY

Prescription Use : Yes

Device Count : 1

SFAM - 00850987007581 Catalog Number : SFAM800 A/B

Device Description : "SFAM800 A/B 8mm ePTFE Block - 3cm X 7cm"

Device Class : 2

Duns Number: 080380106

Premarket Exempt : No

Product Code : KKY

Prescription Use : Yes

Device Count : 1

SFAM - 00850987007598 Catalog Number : SFAM801

Device Description : "SFAM801 8mm ePTFE Block - 5cm X 6cm"

Device Class : 2

Duns Number: 080380106

Premarket Exempt : No

Product Code : KKY

Prescription Use : Yes

Device Count : 1

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