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
XENCO MEDICAL LLC
XM-216-1509
In Commercial Distribution

  • B064XM21615091 ()


  • Spinal fixation plate, non-bioabsorbable
No Description
XENCO MEDICAL LLC
XM-216-1508
In Commercial Distribution

  • B064XM21615081 ()


  • Spinal fixation plate, non-bioabsorbable
No Description
XENCO MEDICAL LLC
XM-216-1507
In Commercial Distribution

  • B064XM21615071 ()


  • Spinal fixation plate, non-bioabsorbable
No Description
XENCO MEDICAL LLC
XM-216-1506
In Commercial Distribution

  • B064XM21615061 ()


  • Spinal fixation plate, non-bioabsorbable
No Description
XENCO MEDICAL LLC
XM-216-1505
In Commercial Distribution

  • B064XM21615051 ()


  • Spinal fixation plate, non-bioabsorbable
No Description
XENCO MEDICAL LLC
XM-216-1504
In Commercial Distribution

  • B064XM21615041 ()


  • Spinal fixation plate, non-bioabsorbable
No Description
XENCO MEDICAL LLC
XM-216-1312
In Commercial Distribution

  • B064XM21613121 ()


  • Spinal fixation plate, non-bioabsorbable
No Description
XENCO MEDICAL LLC
XM-216-1311
In Commercial Distribution

  • B064XM21613111 ()


  • Spinal fixation plate, non-bioabsorbable
No Description
XENCO MEDICAL LLC
XM-216-1310
In Commercial Distribution

  • B064XM21613101 ()


  • Spinal fixation plate, non-bioabsorbable
No Description
XENCO MEDICAL LLC
XM-216-1309
In Commercial Distribution

  • B064XM21613091 ()


  • Spinal fixation plate, non-bioabsorbable
No Description
XENCO MEDICAL LLC
XM-216-1308
In Commercial Distribution

  • B064XM21613081 ()


  • Spinal fixation plate, non-bioabsorbable
No Description
XENCO MEDICAL LLC
XM-216-1307
In Commercial Distribution

  • B064XM21613071 ()


  • Spinal fixation plate, non-bioabsorbable
No Description
XENCO MEDICAL LLC
XM-216-1306
In Commercial Distribution

  • B064XM21613061 ()


  • Spinal fixation plate, non-bioabsorbable
No Description
XENCO MEDICAL LLC
XM-216-1305
In Commercial Distribution

  • B064XM21613051 ()


  • Spinal fixation plate, non-bioabsorbable
No Description
XENCO MEDICAL LLC
XM-216-1304
In Commercial Distribution

  • B064XM21613041 ()


  • Spinal fixation plate, non-bioabsorbable
Collagen wound dressing
NOVABONE PRODUCTS, LLC
BH2210
In Commercial Distribution

  • 00813909010267 ()
  • 00813909010540 ()

  • Width: 25 Millimeter
  • Depth: 1 Millimeter
  • Length: 75 Millimeter
BH2210

  • General oral wound dressing, animal-derived
Saw blade 17 x 6 x 0.4mm for MOS
Nouvag AG
5117NOU
In Commercial Distribution

  • ENOU5117NOU9 ()
  • ENOU5117NOU0 ()


  • Surgical saw blade, oscillating, reusable
Saw blade 12 x 4 x 0.4mm for MOS
Nouvag AG
5115NOU
In Commercial Distribution

  • ENOU5115NOU9 ()
  • ENOU5115NOU0 ()


  • Surgical saw blade, oscillating, reusable
Saw blade 12 x 6 x 0.4mm for MOS
Nouvag AG
5114NOU
In Commercial Distribution

  • ENOU5114NOU9 ()
  • ENOU5114NOU0 ()


  • Surgical saw blade, oscillating, reusable
Saw blade 29 x 12 x 0.4mm for MOS
Nouvag AG
5119NOU
In Commercial Distribution

  • ENOU5119NOU9 ()
  • ENOU5119NOU0 ()


  • Surgical saw blade, oscillating, reusable
Saw blade 17 x 10 x 0.4mm for MOS
Nouvag AG
5118NOU
In Commercial Distribution

  • ENOU5118NOU9 ()
  • ENOU5118NOU0 ()


  • Surgical saw blade, oscillating, reusable
Saw blade 12 x 6 x 0.4mm for MOS
Nouvag AG
5116NOU
In Commercial Distribution

  • ENOU5116NOU9 ()
  • ENOU5116NOU0 ()


  • Surgical saw blade, oscillating, reusable
No Description
ALIMED, INC.
9-503
In Commercial Distribution

  • 00733657244304 ()
2970017446

  • Traction weight
No Description
Feeltech Co.,Ltd.
1FT x FDN38
In Commercial Distribution

  • 18800145513828 ()
  • 08800145513821 ()
  • 28800145513825 ()


  • General-purpose syringe/needle
No Description
Feeltech Co.,Ltd.
1FT x FDN37
In Commercial Distribution

  • 18800145513811 ()
  • 08800145513814 ()
  • 28800145513818 ()


  • General-purpose syringe/needle
No Description
Feeltech Co.,Ltd.
1FT x FDN24
In Commercial Distribution

  • 18800145513804 ()
  • 08800145513807 ()
  • 28800145513801 ()


  • General-purpose syringe/needle
No Description
Feeltech Co.,Ltd.
1FT x FDN3
In Commercial Distribution

  • 18800145513798 ()
  • 08800145513791 ()
  • 28800145513795 ()


  • General-purpose syringe/needle
Sterile Polyester Tipped Applicators
Puritan Medical Products
25-800 2PDBG
In Commercial Distribution

  • 50609576381299 ()
  • 00609576381294 ()
25-800 2PDBG

  • General-purpose absorbent tip applicator/swab, single-use
This product is for the purpose of monitoring accuracy and precision in the quantitative determination of human hemoglobin A1c (HbA1c) in blood by automated immunoassay. For in vitro diagnostic use only. Throughout the circulatory life of the red cell, Hemoglobin A1c is formed continuously by the adduction of glucose to the N-terminal of the hemoglobin beta chain. This process, which is non-enzymatic, reflects the average exposure of hemoglobin to glucose over an extended period.
CLINICAL DIAGNOSTIC SOLUTIONS, INC.
L1 x 2 x 0.5mL, L2 x 2 x 0.5mL
In Commercial Distribution

  • 00812137012166 ()
  • 00812137012449 ()
502-156

  • Glycated haemoglobin (HbA1c) IVD, control
These CRP Controls Set are intended for use in CRP test systems to validate performance of the assay. The controls may also be useful in assessing test precision or analytical errors.2 For in vitro diagnostic use only. C-reactive protein (CRP) is described in the literature as an acute phase protein that is involved in the activation of complement, acceleration of phagocytosis, and detoxification of substances released from damaged tissue. CRP is one of the most sensitive indicators of inflammation.
CLINICAL DIAGNOSTIC SOLUTIONS, INC.
L1 x 3 x 3mL, L2 x 3 x 3mL
In Commercial Distribution

  • 00812137012159 ()
  • 00812137012425 ()
502-155

  • C-reactive protein (CRP) IVD, control
The LDL-Cholesterol Reagent Set is intended for the in vitro quantitative determination of Low Density Lipoprotein Cholesterol in human serum or plasma. The reagents can assist in the diagnosis and treatment of patients at risk of developing coronary heart disease. Elevated LDL cholesterol is the primary target of cholesterol-lowering therapy.
CLINICAL DIAGNOSTIC SOLUTIONS, INC.
R1 x 2 x 70mL, R2 x 1 x 50mL
In Commercial Distribution

  • 00812137012074 ()
  • 00812137012340 ()
501-420

  • Dense low density lipoprotein (DLDL) cholesterol IVD, kit, mass spectrometry
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
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
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.
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.
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.
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.
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.
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
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). 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). 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.
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.
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.
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
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