PECA LABS, INC.

Address:4424 Penn Avenue,Pittsburgh,PA,15224,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

Prosthesis, Vascular Graft, Of 6mm And Greater Diameter (DSY) (10)

Premarket Exempt

Clear

exGraft - 00818136020461 Catalog Number : RUC083501

Device Description : 8mm ID X 35cm Length exGraft Carbon ePTFE Vascular Graft

Device Class :

Duns Number: 078340058

Premarket Exempt : No

Product Code : DSY

Prescription Use : Yes

Device Count : 1

exGraft - 00818136020508 Catalog Number : RUC103501

Device Description : 10mm ID x 35cm length exGraft Carbon ePTFE Vascular Graft

Device Class : 2

Duns Number: 078340058

Premarket Exempt : No

Product Code : DSY

Prescription Use : Yes

Device Count : 1

exGraft - 00818136022267 Catalog Number : RUX033501

Device Description : 3mm ID x 35cm Length exGraft ePTFE Vascular Graft

Device Class : 2

Duns Number: 078340058

Premarket Exempt : No

Product Code : DSY

Prescription Use : Yes

Device Count : 1

exGraft - 00818136022304 Catalog Number : RUX353501

Device Description : 3.5mm ID x 35cm Length exGraft ePTFE vascular graft

Device Class : 2

Duns Number: 078340058

Premarket Exempt : No

Product Code : DSY

Prescription Use : Yes

Device Count : 1

exGraft - 00818136022342 Catalog Number : RUX043501

Device Description : 4mm ID x 35cm Length exGraft ePTFE vascular graft

Device Class : 2

Duns Number: 078340058

Premarket Exempt : No

Product Code : DSY

Prescription Use : Yes

Device Count : 1

exGraft - 00818136022380 Catalog Number : RUX053501

Device Description : 5mm ID x 35cm Length exGraft ePTFE Vascular Graft

Device Class : 2

Duns Number: 078340058

Premarket Exempt : No

Product Code : DSY

Prescription Use : Yes

Device Count : 1

exGraft Carbon - 00818136022540 Catalog Number : RUC043501

Device Description : 4mm ID x 35cm Length exGraft Carbon ePTFE Vascular Graft

Device Class : 2

Duns Number: 078340058

Premarket Exempt : No

Product Code : DSY

Prescription Use : Yes

Device Count : 1

exGraft Carbon - 00818136022588 Catalog Number : RUC053501

Device Description : 5mm ID x 35cm Length exGraft Carbon ePTFE Vascular Graft

Device Class : 2

Duns Number: 078340058

Premarket Exempt : No

Product Code : DSY

Prescription Use : Yes

Device Count : 1

exGraft - 00818136023066 Catalog Number : RUX133501

Device Description : 13mm ID x 35cm Length exGraft ePTFE Vascular Graft

Device Class : 2

Duns Number: 078340058

Premarket Exempt : No

Product Code : DSY

Prescription Use : Yes

Device Count : 1

exGraft - 00818136023097 Catalog Number : RUX192501

Device Description : 19mm ID x 25cm L exGraft ePTFE Vascular Graft

Device Class : 2

Duns Number: 078340058

Premarket Exempt : No

Product Code : DSY

Prescription Use : Yes

Device Count : 1

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