Address:6749 Top Gun St Ste 108,SAN DIEGO,CA,92121,US
Device Description : Bioresorbable protective sheet made from polylactide: a copolymer of 70:30 Poly( Bioresorbable protective sheet made from polylactide: a copolymer of 70:30 Poly(L-lactide-co-D,L-lactide). To be used for management and protection of tendon injuries in which there has been no substantial loss of tendon tissue. Minimizes tissue attachment to the device in case of direct contact with the tissues. Also indicated for reinforcement of soft tissues repaired by suture or suture anchors, during tendon repair surgery. Reinforces soft tissue and provides a remodelable scaffold that is replaced by the patient’s own soft tissue. The device is indicated for open and laparoscopic/endoscopic procedures.
Device Class : 2
Duns Number: 188582360
Premarket Exempt : No
Prescription Use : Yes
Device Description : Bioresorbable protective sheet made from polylactide: a copolymer of 70:30 Poly( Bioresorbable protective sheet made from polylactide: a copolymer of 70:30 Poly(L-lactide-co-D,L-lactide). To be used for management and protection of tendon injuries in which there has been no substantial loss of tendon tissue. Minimizes tissue attachment to the device in case of direct contact with the tissues. Also indicated for reinforcement of soft tissues repaired by suture or suture anchors, during tendon repair surgery. Reinforces soft tissue and provides a remodelable scaffold that is replaced by the patient’s own soft tissue. The device is indicated for open and laparoscopic/endoscopic procedures.
Device Class : 2
Duns Number: 188582360
Premarket Exempt : No
Prescription Use : Yes