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) (9) Prosthesis, Nose, Internal (FZE) (1)

Premarket Exempt

No Yes

Clear

Pureform - 00850987007307 Catalog Number : 7AND02

Device Description : "7AND02 Asian Nasal Dorsum - Curved"

Device Class : 2

Duns Number: 080380106

Premarket Exempt : No

Product Code : FZE

Prescription Use : Yes

Device Count : 1

SFAM - 00850987007314 Catalog Number : eSH-371

Device Description : "ESH-371 1mm ePTFE Sheet (3x7cm)"

Device Class : 2

Duns Number: 080380106

Premarket Exempt : No

Product Code : KKY

Prescription Use : Yes

Device Count : 1

SFAM - 00850987007321 Catalog Number : eSH-372

Device Description : "ESH-372 2mm ePTFE Sheet (3x7cm)"

Device Class : 2

Duns Number: 080380106

Premarket Exempt : No

Product Code : KKY

Prescription Use : Yes

Device Count : 1

SFAM - 00850987007338 Catalog Number : eSH-373

Device Description : "ESH-373 3mm ePTFE Sheet (3x7cm)"

Device Class : 2

Duns Number: 080380106

Premarket Exempt : No

Product Code : KKY

Prescription Use : Yes

Device Count : 1

SFAM - 00850987007345 Catalog Number : eSH-7141

Device Description : "ESH-7141 1mm ePTFE Sheet (7x14cm)"

Device Class : 2

Duns Number: 080380106

Premarket Exempt : No

Product Code : KKY

Prescription Use : Yes

Device Count : 1

SFAM - 00850987007352 Catalog Number : eSH-7142

Device Description : "ESH-7142 2mm ePTFE Sheet (7x14cm)"

Device Class : 2

Duns Number: 080380106

Premarket Exempt : No

Product Code : KKY

Prescription Use : Yes

Device Count : 1

SFAM - 00850987007369 Catalog Number : eSH-7143

Device Description : "ESH-7143 3mm ePTFE Sheet (7x14cm)"

Device Class : 2

Duns Number: 080380106

Premarket Exempt : No

Product Code : KKY

Prescription Use : Yes

Device Count : 1

SFAM - 00850987007376 Catalog Number : eSH-771

Device Description : "ESH-771 1mm ePTFE Sheet (7x7cm)"

Device Class : 2

Duns Number: 080380106

Premarket Exempt : No

Product Code : KKY

Prescription Use : Yes

Device Count : 1

SFAM - 00850987007383 Catalog Number : eSH-772

Device Description : "ESH-772 2mme PTFE Sheet (7x7cm)"

Device Class : 2

Duns Number: 080380106

Premarket Exempt : No

Product Code : KKY

Prescription Use : Yes

Device Count : 1

SFAM - 00850987007390 Catalog Number : eSH-773

Device Description : "ESH-773 3mm ePTFE Sheet (7x7cm)"

Device Class : 2

Duns Number: 080380106

Premarket Exempt : No

Product Code : KKY

Prescription Use : Yes

Device Count : 1

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