SURGICAL TECHNOLOGY LABORATORIES INC

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

Implant, Malar (LZK) (4) Prosthesis, Chin, Internal (FWP) (3) Prosthesis, Nose, Internal (FZE) (3)

Premarket Exempt

No Yes

Clear

PureForm - 00850987007000 Catalog Number : 1EC01

Device Description : 1EC01 - Small ePTFE Chin Implant

Device Class : 2

Duns Number: 080380106

Premarket Exempt : No

Product Code : FWP

Prescription Use : Yes

Device Count : 1

Pureform - 00850987007017 Catalog Number : 1EC02

Device Description : 1EC02 - Medium ePTFE Chin Implant Copy

Device Class : 2

Duns Number: 080380106

Premarket Exempt : No

Product Code : FWP

Prescription Use : Yes

Device Count : 1

Pureform - 00850987007024 Catalog Number : 1EC03

Device Description : 1EC03 - Large ePTFE Chin Implant Copy Copy

Device Class : 2

Duns Number: 080380106

Premarket Exempt : No

Product Code : FWP

Prescription Use : Yes

Device Count : 1

Pureform - 00850987007031 Catalog Number : 1ML01

Device Description : 1ML02 PureForm - ePTFE Malar Implant - Small

Device Class : 2

Duns Number: 080380106

Premarket Exempt : No

Product Code : LZK

Prescription Use : Yes

Device Count : 1

Pureform - 00850987007048 Catalog Number : 1ML02

Device Description : 1ML02 PureForm - ePTFE Malar Implant - Small

Device Class : 2

Duns Number: 080380106

Premarket Exempt : No

Product Code : LZK

Prescription Use : Yes

Device Count : 1

Pureform - 00850987007055 Catalog Number : 1ML03

Device Description : "1ML03 PureForm - ePTFE Malar - Medium"

Device Class : 2

Duns Number: 080380106

Premarket Exempt : No

Product Code : LZK

Prescription Use : Yes

Device Count : 1

Pureform - 00850987007062 Catalog Number : 1ML04

Device Description : "1ML04 PureForm - ePTFE Malar - Large"

Device Class : 2

Duns Number: 080380106

Premarket Exempt : No

Product Code : LZK

Prescription Use : Yes

Device Count : 1

PureForm - 00850987007079 Catalog Number : 2NDP01

Device Description : "2NDP01 PureForm 2mm Pointed Nasal Dorsum - Small"

Device Class : 2

Duns Number: 080380106

Premarket Exempt : No

Product Code : FZE

Prescription Use : Yes

Device Count : 1

Pureform - 00850987007086 Catalog Number : 2NDP02

Device Description : "2NDP02 2mm Pointed Nasal Dorsum - Large"

Device Class : 2

Duns Number: 080380106

Premarket Exempt : No

Product Code : FZE

Prescription Use : Yes

Device Count : 1

Pureform - 00850987007093 Catalog Number : 2NDR01

Device Description : "2NDR01 2mm Rounded Nasal Dorsum - Small"

Device Class : 2

Duns Number: 080380106

Premarket Exempt : No

Product Code : FZE

Prescription Use : Yes

Device Count : 1

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