MAST BIOSURGERY USA INC.

Address:6749 Top Gun St Ste 108,SAN DIEGO,CA,92121,US

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Device Class
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Premarket Exempt
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- Catalog Number : 27202-01

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 wherever temporary wound support is required, to reinforce soft tissues where weakness exists in the urological, gynecological or gastroenterological anatomy or for the repair of hernia or other fascial defects that require the addition of a reinforcing or bridging material to obtain the desired surgical result. Minimizes tissue attachments to the device in case of direct contact with the viscera. Indicated for open and laparoscopic procedures.

Device Class :

Duns Number: 188582360

Premarket Exempt : No

Product Code : FTL

Prescription Use : Yes

Device Count : 1

- Catalog Number : 27204-01

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 wherever temporary wound support is required, to reinforce soft tissues where weakness exists in the urological, gynecological or gastroenterological anatomy or for the repair of hernia or other fascial defects that require the addition of a reinforcing or bridging material to obtain the desired surgical result. Minimizes tissue attachments to the device in case of direct contact with the viscera. Indicated for open and laparoscopic procedures.

Device Class : 2

Duns Number: 188582360

Premarket Exempt : No

Product Code : FTL

Prescription Use : Yes

Device Count : 1

- Catalog Number : 27502-01

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 wherever temporary wound support is required, to reinforce soft tissues where weakness exists in the urological, gynecological or gastroenterological anatomy or for the repair of hernia or other fascial defects that require the addition of a reinforcing or bridging material to obtain the desired surgical result. Minimizes tissue attachments to the device in case of direct contact with the viscera. Indicated for open and laparoscopic procedures.

Device Class : 2

Duns Number: 188582360

Premarket Exempt : No

Product Code : FTL

Prescription Use : Yes

Device Count : 1

- Catalog Number : 27504-01

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 wherever temporary wound support is required, to reinforce soft tissues where weakness exists in the urological, gynecological or gastroenterological anatomy or for the repair of hernia or other fascial defects that require the addition of a reinforcing or bridging material to obtain the desired surgical result. Minimizes tissue attachments to the device in case of direct contact with the viscera. Indicated for open and laparoscopic procedures.

Device Class :

Duns Number: 188582360

Premarket Exempt : No

Product Code : FTL

Prescription Use : Yes

Device Count : 1

- Catalog Number : 36502-01

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). Indicated for use as a pericardium replacement device in patients that may require re-operation within six months.

Device Class : 2

Duns Number: 188582360

Premarket Exempt : No

Product Code : OMH

Prescription Use : Yes

Device Count : 1

- Catalog Number : 36504-01

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). Indicated for use as a pericardium replacement device in patients that may require re-operation within six months.

Device Class : 2

Duns Number: 188582360

Premarket Exempt : No

Product Code : OMH

Prescription Use : Yes

Device Count : 1

- Catalog Number : 47201-01

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 :

Duns Number: 188582360

Premarket Exempt : No

Product Code : FTL

Prescription Use : Yes

Device Count : 1

- Catalog Number : 47501-01

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

Product Code : FTL

Prescription Use : Yes

Device Count : 1

- Catalog Number : 27201-01

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 wherever temporary wound support is required, to reinforce soft tissues where weakness exists in the urological, gynecological or gastroenterological anatomy or for the repair of hernia or other fascial defects that require the addition of a reinforcing or bridging material to obtain the desired surgical result. Minimizes tissue attachments to the device in case of direct contact with the viscera. Indicated for open and laparoscopic procedures.

Device Class : 2

Duns Number: 188582360

Premarket Exempt : No

Product Code : FTL

Prescription Use : Yes

Device Count : 1

- Catalog Number : 27202-01

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 wherever temporary wound support is required, to reinforce soft tissues where weakness exists in the urological, gynecological or gastroenterological anatomy or for the repair of hernia or other fascial defects that require the addition of a reinforcing or bridging material to obtain the desired surgical result. Minimizes tissue attachments to the device in case of direct contact with the viscera. Indicated for open and laparoscopic procedures.

Device Class :

Duns Number: 188582360

Premarket Exempt : No

Product Code : FTL

Prescription Use : Yes

Device Count : 1