Device Description : Reusable bipolar forceps designed to function as active electrodes or as accesso Reusable bipolar forceps designed to function as active electrodes or as accessories to active electrodes.
Device Class : 2
Duns Number: 031284586
Premarket Exempt : No
Prescription Use : Yes
Device Description : Electrosurgical Cords designed to conduct electrical power from the output of a Electrosurgical Cords designed to conduct electrical power from the output of a high frequency generator to a BiPolar instrument.
Device Class : 2
Duns Number: 031284586
Premarket Exempt : No
Prescription Use : Yes
Device Description : DERMACLOSE is a continuous external tissue expander for rapid tissue movement to DERMACLOSE is a continuous external tissue expander for rapid tissue movement to reduce or reapproximate wounds. After initial use, the device does not require added tightening. Depending on the location and size of the wound, one or more DERMACLOSE may be used for hours - days providing tissue expansion. After expansion, remove device and suture or staple the wound closed
Device Class : 1
Duns Number: 031284586
Premarket Exempt : No
Prescription Use : Yes
Device Description : DERMACLOSE XL is a continuous external tissue expander for rapid tissue movement DERMACLOSE XL is a continuous external tissue expander for rapid tissue movement to reduce or reapproximate larger wounds. After initial use, the device does not require added tightening. Depending on the location and size of the wound, one or more devices may be used for hours or days. After expansion, remove device and suture or staple the wound closed.
Device Class : 1
Duns Number: 031284586
Premarket Exempt : No
Prescription Use : Yes
Device Description : The Flow COUPLER Monitor is a pulsed Doppler ultrasound system designed to detec The Flow COUPLER Monitor is a pulsed Doppler ultrasound system designed to detect vessel blood flow and confirm vessel patency intra and post-operatively at the anastomotic site as needed up to 7 days.
Device Class : 2
Duns Number: 031284586
Premarket Exempt : No
Prescription Use : Yes
Device Description : An insulated electrical cord (one piece) designed to connect the Flow COUPLER Mo An insulated electrical cord (one piece) designed to connect the Flow COUPLER Monitor to a mains electricity supply socket. It has four adapters to accommodate voltage specific to the EU, UK, US, and Australia.
Device Class : 2
Duns Number: 031284586
Premarket Exempt : No
Prescription Use : Yes
Device Description : The VESSEL EVERTER System is used with the GEM COUPLER and Flow COUPLER Device t The VESSEL EVERTER System is used with the GEM COUPLER and Flow COUPLER Device to press vessel tissue onto the GEM Flow COUPLER/COUPLER rings, and to measure the vessel, if needed.
Device Class : 2
Duns Number: 031284586
Premarket Exempt : No
Prescription Use : Yes
Device Description : The NEUROTUBE device Absorbable Woven Polyglycolic Acid Mesh Tube is designed fo The NEUROTUBE device Absorbable Woven Polyglycolic Acid Mesh Tube is designed for primary or secondary peripheral nerve repair or reconstruction.
Device Class : 2
Duns Number: 031284586
Premarket Exempt : No
Prescription Use : Yes
Device Description : NEUROTUBE is designed for primary or secondary peripheral nerve repair or recons NEUROTUBE is designed for primary or secondary peripheral nerve repair or reconstruction. The NEUROTUBE device is resorbed through the process of hydrolysis.
Device Class : 2
Duns Number: 031284586
Premarket Exempt : No
Prescription Use : Yes
Device Description : Continuous External Tissue Expander
Device Class : 1
Duns Number: 031284586
Premarket Exempt : No
Prescription Use : Yes