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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
L A P GMBH LASER APPLIKATIONEN
Spacer 60 x 20 x 20mm
In Commercial Distribution

  • 04260590371591 ()
0014463

  • Multi-modality therapeutic radiation phantom, anthropomorphic
No Description
L A P GMBH LASER APPLIKATIONEN
Spacer 80 x 20 x 20mm
In Commercial Distribution

  • 04260590371584 ()
0014462

  • Multi-modality therapeutic radiation phantom, anthropomorphic
No Description
L A P GMBH LASER APPLIKATIONEN
Spacer 100 x 20 x 20mm
In Commercial Distribution

  • 04260590371577 ()
0014461

  • Multi-modality therapeutic radiation phantom, anthropomorphic
154PCS/054PLS - SINGLE USE castable device to be transformed via casting technique in a metal attachment for removable prosthesis. 154STY - SINGLE USE castable device: Accessory of conical shape. 047CSD - DISPOSABLE device in plastic material to be embodied in a removable prosthesis. Cap with extra soft retention 047CSDSN - DISPOSABLE device in plastic material to be embodied in a removable prosthesis. Cap with soft retention
RHEIN 83 SRL
OT STRATEGY x DUPLICATION x USA
In Commercial Distribution

098SSSUS

  • Dental implant suprastructure, permanent, preformed
No Description
CRAWFORD HEALTHCARE LIMITED
4 x 4 x 0.1 in
In Commercial Distribution

  • 05060077234093 ()
  • 05060077230385 ()
  • 05060077230439 ()

  • Depth: 0.1 Inch
  • Length: 4 Inch
  • Height: 4 Inch
KPRO10

  • Pressure-management bandage, silicone
SINGLE USE castable device to be transformed via casting technique in a metal attachment for removable prosthesis.
RHEIN 83 SRL
OT STRATEGY x DUPLICATION x USA
Not in Commercial Distribution

  • D821098SSSUS0 ()
098SSSUS

  • Dental implant suprastructure, permanent, preformed
The Invuity Steam Sterilization Tray is intended to allow sterilization of the enclosed medical devices.
INVUITY, INC.
1.5 x 10 x 15 in
In Commercial Distribution

  • 00816728020295 ()

  • Length: 15 Inch
  • Width: 10 Inch
  • Height: 1.5 Inch
11185

  • Device sterilization/disinfection container, reusable
The Invuity Steam Sterilization Tray is intended to allow sterilization of the enclosed medical devices.
INVUITY, INC.
1.5 x 6 x 10 in
In Commercial Distribution

  • 00816728020288 ()

  • Length: 10 Inch
  • Width: 6 Inch
  • Height: 1.5 Inch
11070

  • Device sterilization/disinfection container, reusable
For the quantitative determination of C-reactive protein in serum or plasma by latex particle enhanced immunoturbidimetric assay. For in vitro diagnostic use only. C-reactive protein (CRP) is an acute phase protein that is involved in the activation of complement, acceleration of phagocytosis, and detoxification of substances released from damaged tissue. As such, CRP is considered to be one of the most sensitive indicators of inflammation.
CLINICAL DIAGNOSTIC SOLUTIONS, INC.
R1 x 50mL, R2 x 50mL
In Commercial Distribution

  • 00812137012098 ()
  • 00812137012364 ()
501-435

  • C-reactive protein (CRP) IVD, reagent
For the in vitro quantitative kinetic determination of lactate dehydrogenase activity in serum. Increased levels of LD are associated with myocardial infarction. Levels reach a maximum approximately 48 hours after the onset of pain and persist about ten days. The degree of elevation is of value in assessing the extent of damage and in developing a prognosis. LD elevations are also observed in liver disease, pernicious anemia, in some cases of renal disease, and in some cases of skeletal muscle trauma.
CLINICAL DIAGNOSTIC SOLUTIONS, INC.
R1 x 500mL, R2 x 125mL
In Commercial Distribution

  • 00812137012005 ()
  • 00812137012333 ()
501-413

  • Lactate dehydrogenase 5 (LDH-5) isoenzyme IVD, reagent
For the quantitative determination of iron in serum. For in vitro diagnostic use only.
CLINICAL DIAGNOSTIC SOLUTIONS, INC.
R1 x 500mL, R2 x 15mL
In Commercial Distribution

  • 00812137011992 ()
  • 00812137012326 ()
501-412

  • Iron IVD, reagent
For the quantitative kinetic determination of gamma glutamyl transferase (GGT) activity in serum. GGT measurements are used in the diagnosis and treatment of liver diseases such as alcoholic cirrhosis, and primary and secondary tumors. Elevated GGT levels appear earlier and are more pronounced than those of other liver enzymes, in cases of obstructive jaundice and metastatic neoplasms.
CLINICAL DIAGNOSTIC SOLUTIONS, INC.
R1 x 500mL, R2 x 125mL
In Commercial Distribution

  • 00812137011978 ()
  • 00812137012302 ()
501-410

  • Gamma-glutamyltransferase (GGT) IVD, reagent
For the quantitative determination of creatinine in serum. For in vitro diagnostic use only. Creatinine assays are most frequently performed to aid in the determination of renal function.
CLINICAL DIAGNOSTIC SOLUTIONS, INC.
R1 x 500mL, R2 x 125mL
In Commercial Distribution

  • 00812137011961 ()
  • 00812137012296 ()
501-409

  • Creatinine IVD, reagent
For the quantitative determination of creatine kinase activity in serum. Serum creatinine kinase (CK) levels have proven valuable in the assessment of cardiac and skeletal muscle diseases, including myocardial infarction and muscular dystrophy.¹ Determination of creatine kinase and lactate dehydrogenase isoenzymes provides a definitive diagnosis of acute myocardial infarction.
CLINICAL DIAGNOSTIC SOLUTIONS, INC.
R1 x 120mL, R2 x 30mL
In Commercial Distribution

  • 00812137011954 ()
  • 00812137012289 ()
501-408

  • Creatine kinase (CK) multiple isoenzyme IVD, reagent
For the quantitative determination of urea nitrogen in serum. For in vitro diagnostic use only. Determination of urea nitrogen in serum is widely used as a screening test for renal function. When used in conjunction with the determination of creatinine in serum it is helpful in the differential diagnosis of the three types of azotemia; pre-renal, renal and post-renal.
CLINICAL DIAGNOSTIC SOLUTIONS, INC.
R1 x 500mL, R2 x 125mL
In Commercial Distribution

  • 00812137011916 ()
  • 00812137012272 ()
501-404

  • Urea IVD, kit, enzyme spectrophotometry
For the quantitative determination of total bilirubin in serum.
CLINICAL DIAGNOSTIC SOLUTIONS, INC.
R1 x 500mL, R2 x 15mL
In Commercial Distribution

  • 00812137011909 ()
  • 00812137012265 ()
501-403

  • Total bilirubin IVD, kit, enzyme spectrophotometry
For the quantitative determination of direct bilirubin in serum.
CLINICAL DIAGNOSTIC SOLUTIONS, INC.
R1 x 500mL, R2 x 15mL
In Commercial Distribution

  • 00812137011893 ()
  • 00812137012258 ()
501-402

  • Conjugated (direct) bilirubin IVD, kit, enzyme spectrophotometry
For the quantitative determination of Aspartate Aminotransferase (AST) in human serum. AST is widely distributed in tissues with the highest concentrations found in the liver, heart, skeletal muscle and kidneys. Diseases involving any of these tissues can lead to elevated levels of AST in serum. Following myocardial infarction, AST levels are elevated and reach a peak after 48 to 60 hours. Hepatobiliary diseases such as cirrhosis, metastatic carcinoma and viral hepatitis can show increased levels of AST. Other disorders which can lead to an elevated level of AST are muscular dystrophy, dermatomyositis, acute pancreatitis and infectious mononucleosis.
CLINICAL DIAGNOSTIC SOLUTIONS, INC.
R1 x 500mL, R2 x 125mL
In Commercial Distribution

  • 00812137011886 ()
  • 00812137012241 ()
501-401

  • Total aspartate aminotransferase (AST) IVD, kit, spectrophotometry
For the quantitative determination of Alanine Aminotransferase in serum. ALT is widely distributed in tissues with the highest concentrations found in the liver and kidneys. Even so, ALT is considered more liver-specific than AST. Elevated levels of ALT are often only observed in liver diseases such as cirrhosis, hepatitis, or metastatic carcinoma. However, there can be elevated levels of ALT with infectious mononucleosis, muscular dystrophy, and dermatomyositis.
CLINICAL DIAGNOSTIC SOLUTIONS, INC.
R1 x 500mL, R2 x 125mL
In Commercial Distribution

  • 00812137011862 ()
  • 00812137012227 ()
501-399

  • Alanine aminotransferase (ALT) IVD, kit, enzyme spectrophotometry
ArtiFascia® is an absorbable dural repair graft for the repair of cranial dural defects. ArtiFascia® is a highly flexible, easy to handle, non-friable soft matrix composed of synthetic non-woven fibers and a non-porous film. ArtiFascia® readily conforms to the surface of the wound area and is applied to the dural defect by using sutures.
NURAMI MEDICAL LTD
7cm X 7cm (2.75" X 2.75")
In Commercial Distribution

  • 07290019685029 ()

  • 7cm X 7cm (2.75 Inches X 2.75 Inches)
ART7701

  • Dura mater graft, synthetic
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