DURASTAT LLC

Address:304 National Road,Exton,PA,19341,US

Want to know more about this Organization? Request more information now!

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

Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene (NBY) (1)

Premarket Exempt

Clear

DuraStat - B532GZL0020 Catalog Number :

Device Description : DuraStat is indicated for use in general soft tissue approximation and/or ligati DuraStat is indicated for use in general soft tissue approximation and/or ligation, including: cardiovascular, dental, general surgical procedures and repair of the dura mater. DuraStat PTFE sutures are not indicated for use in microsurgery, ophthalmic procedures, or peripheral neural tissues. DuraStat is provided sterile as a single-use device.

Device Class : 2

Duns Number: 080315253

Premarket Exempt : No

Product Code : NBY

Prescription Use : Yes

Device Count : 1

Previous 1 Next