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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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Total Bilirubin Reagent Set - 00812137011909

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

Direct Bilirubin Reagent Set - 00812137011893

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

AST (SGOT) Reagent Set - 00812137011886

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

ALT (SGPT) Reagent Set - 00812137011862

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

Invuity® Steam Sterilization Tray - 00816728020295

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

Invuity® Steam Sterilization Tray - 00816728020288

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

DENTAL ATTACHMENTS - 08059224015668

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

Control Samples US - 07332699000737

No Description
M DIALYSIS INC.
5 x Low, 5 x Elevated
In Commercial Distribution

  • 07332699000737 ()
8010306

  • Microdialysis system

Glycerol reagent - 07332699000294

No Description
M DIALYSIS INC.
5 x Reagent, 5 x Buffer
In Commercial Distribution

  • 07332699000294 ()
P000025

  • Microdialysis system

Glucose reagent - 07332699000652

No Description
M DIALYSIS INC.
5 x Reagent, 5 x Buffer
In Commercial Distribution

  • 07332699000652 ()
P000023

  • Microdialysis system

Pyruvate reagent - 07332699000324

No Description
M DIALYSIS INC.
5 x Reagent, 5 x Buffer
In Commercial Distribution

  • 07332699000324 ()
P000063

  • Microdialysis system

Lactate reagent - 07332699000317

No Description
M DIALYSIS INC.
5 x Reagent, 5 x Buffer
In Commercial Distribution

  • 07332699000317 ()
P000024

  • Microdialysis system

Glutamate reagent - 07332699000287

No Description
M DIALYSIS INC.
5 x Reagent, 5 x Buffer
In Commercial Distribution

  • 07332699000287 ()
P000064

  • Microdialysis system

IMPROSAFE® Blood Collection Set with Pre-Attached Holder - 06974481831078

No Description
Guangzhou Improve Medical Instruments Co., Ltd.
23G x 3/4” x 7”
In Commercial Distribution

  • 16974481831075 ()
  • 06974481831078 ()
  • 46974481831076 ()
  • 56974481831073 ()
  • 26974481831072 ()
  • 76974481831077 ()


  • Non-fixed blood collection needle

IMPROSAFE® Blood Collection Set with Pre-Attached Holder - 06974481831030

No Description
Guangzhou Improve Medical Instruments Co., Ltd.
23G x 3/4” x 12”
In Commercial Distribution

  • 16974481831037 ()
  • 06974481831030 ()
  • 26974481831034 ()
  • 76974481831039 ()
  • 46974481831038 ()
  • 56974481831035 ()


  • Non-fixed blood collection needle

IMPROSAFE® Blood Collection Set - 06974481831009

No Description
Guangzhou Improve Medical Instruments Co., Ltd.
25G x 3/4” x 7”
In Commercial Distribution

  • 16974481831006 ()
  • 06974481831009 ()
  • 26974481831003 ()
  • 86974481831005 ()
  • 46974481831007 ()
  • 56974481831004 ()
  • 66974481831001 ()
  • 76974481831008 ()
  • 96974481831002 ()


  • Non-fixed blood collection needle

IMPROSAFE® Blood Collection Set - 06974481830996

No Description
Guangzhou Improve Medical Instruments Co., Ltd.
23G x 3/4” x 7”
In Commercial Distribution

  • 16974481830993 ()
  • 06974481830996 ()
  • 26974481830990 ()
  • 86974481830992 ()
  • 46974481830994 ()
  • 56974481830991 ()
  • 66974481830998 ()
  • 76974481830995 ()
  • 96974481830999 ()


  • Non-fixed blood collection needle

IMPROSAFE® Blood Collection Set - 06974481830965

No Description
Guangzhou Improve Medical Instruments Co., Ltd.
25G x 3/4” x 12”
In Commercial Distribution

  • 16974481830962 ()
  • 06974481830965 ()
  • 26974481830969 ()
  • 86974481830961 ()
  • 46974481830963 ()
  • 56974481830960 ()
  • 66974481830967 ()
  • 76974481830964 ()
  • 96974481830968 ()


  • Non-fixed blood collection needle

IMPROSAFE® Blood Collection Set - 06974481830958

No Description
Guangzhou Improve Medical Instruments Co., Ltd.
23G x 3/4” x 12”
In Commercial Distribution

  • 06974481830958 ()
  • 16974481830955 ()
  • 46974481830956 ()
  • 56974481830953 ()
  • 66974481830950 ()
  • 76974481830957 ()
  • 96974481830951 ()
  • 26974481830952 ()
  • 86974481830954 ()


  • Non-fixed blood collection needle

ArtiFascia® - 07290019685029

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

ArtiFascia® - 07290019685012

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
5cm X 5cm (1.96" X 1.96")
In Commercial Distribution

  • 07290019685012 ()

  • 5cm X 5cm (1.96 Inches X 1.96 Inches)
ART5501

  • Dura mater graft, synthetic

ArtiFascia® - 07290019685005

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
3cm X 4cm (1.18" X 1.57")
In Commercial Distribution

  • 07290019685005 ()

  • 3cm X 4cm (1.18 Inches X 1.57 Inches)
ART3401

  • Dura mater graft, synthetic

Cimeosil® Scar Management, Gel Sheet - M724GS10121

Scar Management, Gel Sheet
IMPLANTECH ASSOCIATES, INC.
10" x 12" (25.4cm x 30.5cm)
In Commercial Distribution

  • M724GS10121 ()
GS-10-12

  • Scar-management dressing, reusable

Cimeosil® Scar Management, Gel Sheet - M724GS04051

Scar Management, Gel Sheet
IMPLANTECH ASSOCIATES, INC.
4" x 5" (10.2cm x 12.7cm)
In Commercial Distribution

  • M724GS04051 ()
GS-04-05

  • Scar-management dressing, reusable

ePTFE Sheet - M724EPTFESHEET0211

ePTFE Sheet
IMPLANTECH ASSOCIATES, INC.
Size: 8cm x 5cm x 2mm
In Commercial Distribution

  • M724EPTFESHEET0211 ()
EPTFE-SHEET-021

  • PTFE/carbon-fibre craniofacial tissue reconstructive material

ePTFE Sheet - M724EPTFESHEET0131

ePTFE Sheet
IMPLANTECH ASSOCIATES, INC.
Size: 12cm x 6cm x 1mm
In Commercial Distribution

  • M724EPTFESHEET0131 ()
EPTFE-SHEET-013

  • PTFE/carbon-fibre craniofacial tissue reconstructive material

ePTFE Sheet - M724EPTFESHEET0101

ePTFE Sheet
IMPLANTECH ASSOCIATES, INC.
Size: 8cm x 5cm x 1mm
In Commercial Distribution

  • M724EPTFESHEET0101 ()
EPTFE-SHEET-010

  • PTFE/carbon-fibre craniofacial tissue reconstructive material

Calf Implant, Smooth SDM - M724CCB7S511

Calf Implant
IMPLANTECH ASSOCIATES, INC.
Size: 16.0cm x 9.0cm x 2.0cm
In Commercial Distribution

  • M724CCB7S511 ()
CCB7-S-51

  • Silicone-block tissue reconstructive material

Calf Implant, Smooth SDM - M724CCB7S411

Calf Implant
IMPLANTECH ASSOCIATES, INC.
Size: 14.5cm x 7.5cm x 1.7cm
In Commercial Distribution

  • M724CCB7S411 ()
CCB7-S-41

  • Silicone-block tissue reconstructive material

Calf Implant, Smooth SDM - M724CCB7S311

Calf Implant
IMPLANTECH ASSOCIATES, INC.
Size: 14.3cm x 6.5cm x 1.6cm
In Commercial Distribution

  • M724CCB7S311 ()
CCB7-S-31

  • Silicone-block tissue reconstructive material

Calf Implant, Smooth SDM - M724CCB7S211

Calf Implant
IMPLANTECH ASSOCIATES, INC.
Size: 12.7cm x 6.0cm x 1.5cm
In Commercial Distribution

  • M724CCB7S211 ()
CCB7-S-21

  • Silicone-block tissue reconstructive material

Calf Implant, Smooth SDM - M724CCB7S111

Calf Implant
IMPLANTECH ASSOCIATES, INC.
Size: 12.0cm x 5.2cm x 1.3cm
In Commercial Distribution

  • M724CCB7S111 ()
CCB7-S-11

  • Silicone-block tissue reconstructive material

Gluteal Implant, Round, Textured, SDM - M724CCB6T831

Gluteal Implant
IMPLANTECH ASSOCIATES, INC.
Size: 17.0cm x 13.5cm x 4.0cm
In Commercial Distribution

  • M724CCB6T831 ()
CCB6-T-83

  • Silicone-block tissue reconstructive material

Gluteal Implant, Round, Textured, SDM - M724CCB6T811

Gluteal Implant
IMPLANTECH ASSOCIATES, INC.
Size: 15.5cm x 12.5cm x 3.5cm
In Commercial Distribution

  • M724CCB6T811 ()
CCB6-T-81

  • Silicone-block tissue reconstructive material

Gluteal Implant, Round, Textured, SDM - M724CCB6T741

Gluteal Implant
IMPLANTECH ASSOCIATES, INC.
Size: 17.0cm x 12.5cm x 3.5cm
In Commercial Distribution

  • M724CCB6T741 ()
CCB6-T-74

  • Silicone-block tissue reconstructive material

Gluteal Implant, Round, Textured, SDM - M724CCB6T731

Gluteal Implant
IMPLANTECH ASSOCIATES, INC.
Size: 16.5cm x 12.0cm x 3.2cm
In Commercial Distribution

  • M724CCB6T731 ()
CCB6-T-73

  • Silicone-block tissue reconstructive material

Gluteal Implant, Round, Textured, SDM - M724CCB6T721

Gluteal Implant
IMPLANTECH ASSOCIATES, INC.
Size: 16.0cm x 11.0cm x 3.0cm
In Commercial Distribution

  • M724CCB6T721 ()
CCB6-T-72

  • Silicone-block tissue reconstructive material

Gluteal Implant, Round, Textured, SDM - M724CCB6T711

Gluteal Implant
IMPLANTECH ASSOCIATES, INC.
Size: 15.0cm x 10.5cm x 2.5cm
In Commercial Distribution

  • M724CCB6T711 ()
CCB6-T-71

  • Silicone-block tissue reconstructive material

Dr. Stanton Symmetrical Oval Smooth - M724CCB6S851

Contoured Carving Block Implant
IMPLANTECH ASSOCIATES, INC.
Size: 18.7cm x 15.0cm x 5.5cm
In Commercial Distribution

  • M724CCB6S851 ()
CCB6-S-85

  • Silicone-block tissue reconstructive material

Dr. Stanton Symmetrical Oval Smooth - M724CCB6S841

Contoured Carving Block Implant
IMPLANTECH ASSOCIATES, INC.
Size: 18.0cm x 14.0cm x 4.5cm
In Commercial Distribution

  • M724CCB6S841 ()
CCB6-S-84

  • Silicone-block tissue reconstructive material
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