ON-X LIFE TECHNOLOGIES, INC.

Address:1300 East anderson Lane,Austin,TX,78752,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

Nonabsorbable Expanded Polytetrafluoroethylene Surgical Suture For Chordae Tendinae Repair Or Replacement (PAW) (10)

Premarket Exempt

Clear

Chord-X Premeasured Loops and Suture System - 00813570020008 Catalog Number : CXL-20-2212-0

Device Description : Artificial chordal replacement prosthesis

Device Class : 2

Duns Number: 844782318

Premarket Exempt : No

Product Code : PAW

Prescription Use : Yes

Device Count : 1

Chord-X Premeasured Loops and Suture System - 00813570020015 Catalog Number : CXL-20-2212-12

Device Description : Artificial chordal replacement prosthesis

Device Class :

Duns Number: 844782318

Premarket Exempt : No

Product Code : PAW

Prescription Use : Yes

Device Count : 1

Chord-X Premeasured Loops and Suture System - 00813570020022 Catalog Number : CXL-20-2212-16

Device Description : Artificial chordal replacement prosthesis

Device Class : 2

Duns Number: 844782318

Premarket Exempt : No

Product Code : PAW

Prescription Use : Yes

Device Count : 1

Chord-X Premeasured Loops and Suture System - 00813570020039 Catalog Number : CXL-20-2212-20

Device Description : Artificial chordal replacement prosthesis

Device Class : 2

Duns Number: 844782318

Premarket Exempt : No

Product Code : PAW

Prescription Use : Yes

Device Count : 1

Chord-X Premeasured Loops and Suture System - 00813570020046 Catalog Number : CXL-20-2212-24

Device Description : Artificial chordal replacement prosthesis

Device Class : 2

Duns Number: 844782318

Premarket Exempt : No

Product Code : PAW

Prescription Use : Yes

Device Count : 1

Chord-X Premeasured Loops and Suture System - 00813570020053 Catalog Number : CXL-20-2238-0

Device Description : Artificial chordal replacement prosthesis

Device Class : 2

Duns Number: 844782318

Premarket Exempt : No

Product Code : PAW

Prescription Use : Yes

Device Count : 1

Chord-X Premeasured Loops and Suture System - 00813570020060 Catalog Number : CXL-20-2238-12

Device Description : Artificial chordal replacement prosthesis

Device Class : 2

Duns Number: 844782318

Premarket Exempt : No

Product Code : PAW

Prescription Use : Yes

Device Count : 1

Chord-X Premeasured Loops and Suture System - 00813570020077 Catalog Number : CXL-20-2238-16

Device Description : Artificial chordal replacement prosthesis

Device Class : 2

Duns Number: 844782318

Premarket Exempt : No

Product Code : PAW

Prescription Use : Yes

Device Count : 1

Chord-X Premeasured Loops and Suture System - 00813570020084 Catalog Number : CXL-20-2238-20

Device Description : Artificial chordal replacement prosthesis

Device Class : 2

Duns Number: 844782318

Premarket Exempt : No

Product Code : PAW

Prescription Use : Yes

Device Count : 1

Chord-X Premeasured Loops and Suture System - 00813570020091 Catalog Number : CXL-20-2238-24

Device Description : Artificial chordal replacement prosthesis

Device Class : 2

Duns Number: 844782318

Premarket Exempt : No

Product Code : PAW

Prescription Use : Yes

Device Count : 1

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