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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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No Description
R.D.J. TOV IMPLANT LTD
5 x 10mm
In Commercial Distribution

  • 07290117800188 ()
MAER5L10

  • Dental implant system
No Description
R.D.J. TOV IMPLANT LTD
5 x 8mm
In Commercial Distribution

  • 07290117800171 ()
MAER5L8

  • Dental implant system
No Description
APIFIX LTD
Extender - Lenke 5
In Commercial Distribution

  • 07290018128374 ()


  • Mechanical spinal distraction rod extender
Straight Rod of the CarboClear Pedicle Screw System
CARBOFIX ORTHOPEDICS LTD
Rod - Type 5
In Commercial Distribution

  • 17290110200760 ()
  • 07290110200763 ()

  • Length: 270 Millimeter
  • Outer Diameter: 6 Millimeter
PPLSR6270

  • Bone-screw internal spinal fixation system rod
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.
MAST BIOSURGERY USA INC.
50 x 70 x 0.05mm
Not in Commercial Distribution

  • 18964050475012 ()
  • 08964050475015 ()

  • Thickness: 0.05 Millimeter
  • Length: 70 Millimeter
  • Width: 50 Millimeter
47501-01

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable
Bioresorbable protective sheet made from polylactide: a copolymer of 70:30 Poly(L-lactide-co-D,L-lactide). To be used as a pericardium replacement device in patients that may require re-operation within six months.
MAST BIOSURGERY USA INC.
130 x 200 x 0.05mm
Not in Commercial Distribution

  • 18964050365047 ()
  • 08964050365040 ()

  • Thickness: 0.05 Millimeter
  • Length: 200 Millimeter
  • Width: 130 Millimeter
36504-01

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable
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.
MAST BIOSURGERY USA INC.
130 x 200 x 0.02mm
Not in Commercial Distribution

  • 18964050362046 ()
  • 08964050362049 ()

  • Width: 130 Millimeter
  • Length: 200 Millimeter
  • Thickness: 0.02 Millimeter
36204-01

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable
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.
MAST BIOSURGERY USA INC.
130 x 200 x 0.02mm
Not in Commercial Distribution

  • 18964050272048 ()
  • 08964050272041 ()

  • Thickness: 0.02 Millimeter
  • Length: 200 Millimeter
  • Width: 130 Millimeter
27204-01

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable
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.
MAST BIOSURGERY USA INC.
100 x 130 x 0.02mm
Not in Commercial Distribution

  • 08964050272027 ()
  • 18964050272024 ()

  • Thickness: 0.02 Millimeter
  • Width: 100 Millimeter
  • Length: 130 Millimeter
27202-01

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable
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.
MAST BIOSURGERY USA INC.
50 x 70 x 0.02mm
Not in Commercial Distribution

  • 18964050472011 ()
  • 08964050472014 ()

  • Width: 50 Millimeter
  • Length: 70 Millimeter
  • Thickness: 0.02 Millimeter
47201-01

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable
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