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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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The HDL-Cholesterol Reagent Set is intended for the in vitro quantitative determination of High Density Lipoprotein Cholesterol in human serum or plasma. The reagent can assist in the diagnosis and treatment of patients at risk for developing coronary heart disease.
CLINICAL DIAGNOSTIC SOLUTIONS, INC.
R1 x 2 x 70mL, R2 x 1 x 50mL
In Commercial Distribution

  • 00812137012067 ()
  • 00812137012319 ()
501-419

  • High density lipoprotein (HDL) cholesterol IVD, reagent
For the quantitative determination of magnesium in serum. For in vitro diagnostic use only. Magnesium in the body is found primarily in bone with some in soft tissue, blood cells, and serum. Decreased levels have been observed in cases of diabetes, alcoholism, diuretics, hyperthyroidism, hypothyroidism, malabsorption, hyperalimenation, myocardial infarction, congestive heart failure and liver cirrhosis. Increased serum magnesium levels have been found in renal failure, diabetic acidosis, Addison’s disease, and vitamin D intoxication.
CLINICAL DIAGNOSTIC SOLUTIONS, INC.
R1 x 2 x 120mL, R2 x 2 x 120mL
In Commercial Distribution

  • 00812137012012 ()
  • 00812137012364 ()
501-414

  • Magnesium (Mg2+) IVD, reagent
No Description
CRAWFORD HEALTHCARE LIMITED
20 x 1 x 0.1in
In Commercial Distribution

  • 05060077234123 ()
  • 05060077230644 ()
  • 05060077230637 ()
KPRO60

  • Pressure-management bandage, silicone
No Description
CRAWFORD HEALTHCARE LIMITED
12 x 2 x 0.1in
In Commercial Distribution

  • 05060077234116 ()
  • 05060077230620 ()
  • 05060077230583 ()
KPRO50

  • Pressure-management bandage, silicone
No Description
CRAWFORD HEALTHCARE LIMITED
4 x 4 x 0.5in
In Commercial Distribution

  • 05060077230392 ()
  • 05060077230446 ()
  • 05060077234109 ()

  • Depth: 0.5 Inch
  • Length: 4 Inch
  • Height: 4 Inch
KPRO20

  • Pressure-management bandage, silicone
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 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
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.
100 x 130 x 0.05mm
Not in Commercial Distribution

  • 18964050365023 ()
  • 08964050365026 ()

  • Width: 100 Millimeter
  • Length: 130 Millimeter
  • Thickness: 0.05mm
36502-01

  • 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). Indicated for use as a pericardium replacement device in patients that may require re-operation within six months.
MAST BIOSURGERY USA INC.
100 x 130 x 0.02mm
Not in Commercial Distribution

  • 18964050362022 ()
  • 08964050362025 ()

  • Length: 130 Millimeter
  • Width: 100 Millimeter
  • Thickness: 0.02 Millimeter
36202-01

  • 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.
180 x 280 x 0.05mm
Not in Commercial Distribution

  • 18964050275063 ()
  • 08964050275066 ()

  • Width: 180 Millimeter
  • Thickness: 0.05mm
  • Length: 280 Millimeter
27506-01

  • 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 0.05mm
Not in Commercial Distribution

  • 08964050275042 ()
  • 18964050275049 ()

  • Thickness: 0.05mm
  • Width: 130 Millimeter
  • Length: 200 Millimeter
27504-01

  • 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 0.05mm
Not in Commercial Distribution

  • 08964050275028 ()
  • 18964050275025 ()

  • Thickness: 0.05mm
  • Length: 130 Millimeter
  • Width: 100 Millimeter
27502-01

  • 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.
50 x 70 x 0.05mm
Not in Commercial Distribution

  • 08964050275011 ()

  • Thickness: 0.05mm
  • Length: 70 Millimeter
  • Width: 50 Millimeter
27501-01

  • 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.
180 x 280 x 0.02mm
Not in Commercial Distribution

  • 18964050272062 ()
  • 08964050272065 ()

  • Thickness: 0.02 Millimeter
  • Length: 280 Millimeter
  • Width: 180 Millimeter
27206-01

  • 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 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.
50 x 70 x 0.02mm
Not in Commercial Distribution

  • 08964050272010 ()

  • Thickness: 0.02 Millimeter
  • Length: 70 Millimeter
  • Width: 50 Millimeter
27201-01

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable
No Description
soosung medical
5cm x 5cm x 8p
In Commercial Distribution

  • 08809968579984 ()
  • 08809968579977 ()
  • 08809968579991 ()
  • 08809968579885 ()


  • Woven gauze pad, non-antimicrobial
No Description
soosung medical
7.5cm x 7.5cm x 8p
In Commercial Distribution

  • 08809968579953 ()
  • 08809968579946 ()
  • 08809968579960 ()
  • 08809968579892 ()


  • Woven gauze pad, non-antimicrobial
No Description
soosung medical
10cm x 10cm x 8p
In Commercial Distribution

  • 08809968579922 ()
  • 08809968579915 ()
  • 08809968579939 ()
  • 08809968579908 ()


  • Woven gauze pad, non-antimicrobial
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.
50mm x 70mm x 0.05mm
In Commercial Distribution

  • 00810057380334 ()
  • 00810057380402 ()

  • 50mm x 70mm x 0.05mm
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 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.
50mm x 70mm x 0.02mm
In Commercial Distribution

  • 00810057380389 ()
  • 00810057380327 ()

  • 70MM x 50mm x 0.05mm
47201-01

  • 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 0.05mm
In Commercial Distribution

  • 00810057380266 ()

  • 130mm x 200mm x 0.05mm
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.
100 x 130 x 0.05mm
In Commercial Distribution

  • 00810057380259 ()

  • 100mm x 130mm x 0.05mm
36502-01

  • 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 0.05mm
In Commercial Distribution

  • 00810057380198 ()
  • 00810057380204 ()

  • 130mm x 200mm x 0.05mm
27504-01

  • 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 0.05mm
In Commercial Distribution

  • 00810057380181 ()
  • 00810057380174 ()

  • 100mm x 130mm x 0.05mm
27502-01

  • 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
In Commercial Distribution

  • 00810057380167 ()
  • 00810057380150 ()

  • 130mm x 200mm x 0.02mm
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
In Commercial Distribution

  • 00810057380136 ()
  • 00810057380143 ()

  • 100mm x 130mm x 0.02mm
27202-01

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable
No Description
Medshape, Inc.
3000-10-32161412
In Commercial Distribution

  • M970300010321614120 ()


  • Orthopaedic bone staple, non-adjustable
No Description
Medshape, Inc.
3000-10-28161412
In Commercial Distribution

  • M970300010281614120 ()


  • Orthopaedic bone staple, non-adjustable
No Description
Medshape, Inc.
3000-10-24161412
In Commercial Distribution

  • M970300010241614120 ()


  • Orthopaedic bone staple, non-adjustable
Dental Composite resin
Kulzer GmbH
66004969
In Commercial Distribution

  • J014660049691 ()
66004969

  • Dental composite resin
Material Impression
Kulzer GmbH
66004969
Not in Commercial Distribution

  • J014660049690 ()
66004969

  • Polyether dental impression material
Dental Composite resin
Kulzer GmbH
66004965
In Commercial Distribution

  • J014660049651 ()
66004965

  • Dental composite resin
Material Impression
Kulzer GmbH
66004965
Not in Commercial Distribution

  • J014660049650 ()
66004965

  • Polyether dental impression material
Dermisplus Prevent Strip 20 x 1 x 0.1in (pk of 5)
Frontier Therapeutics Inc
8500001
In Commercial Distribution

  • 05056279304108 ()


  • Pressure-management bandage, silicone
Dermisplus Prevent Strip 12 x 2 x 0.1in (pk of 5)
Frontier Therapeutics Inc
8500006
In Commercial Distribution

  • 05056279304092 ()


  • Pressure-management bandage, silicone
Dermisplus Prevent Pad 8 x 8 x 0.5in (Pk of 2)
Frontier Therapeutics Inc
8500009
In Commercial Distribution

  • 05056279304085 ()


  • Pressure-management bandage, silicone
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