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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 SAMI Hemofiltration Cassette is provided sterile, single use only, and has a non-toxic, non-pyrogenic fluid path. The package is sterile if the package is intact, undamaged, and protective caps are secure. The cassette tubing set is a single line set including venous and arterial blood paths and is provided as a single unit in a sterile pouch.
Spectral Medical Inc
SM-200-003
Not in Commercial Distribution

  • B173SM2000030 ()
SM-200-003

  • Haemodialysis blood tubing set, single-use
The SAMI RRT Cassette is provided sterile, single use only, and has a non-toxic, non-pyrogenic fluid path. The package is sterile if the package is intact, undamaged, and protective caps are secure. The cassette tubing set is a single line set including venous and arterial blood paths and is provided as a single unit in a sterile pouch.
Spectral Medical Inc
SA-400-00
Not in Commercial Distribution

  • B173SA400000 ()
SA-400-00

  • Haemodialysis blood tubing set, single-use
The SAMI RRT Cassette is provided sterile, single use only, and has a non-toxic, non-pyrogenic fluid path. The package is sterile if the package is intact, undamaged, and protective caps are secure. The cassette tubing set is a single line set including venous and arterial blood paths and is provided as a single unit in a sterile pouch.
I-Dialco Inc
SA-400-00
In Commercial Distribution

  • 07540161930226 ()
  • 17540161930223 ()
  • 27540161930220 ()
SA-400-00

  • Haemodialysis blood tubing set, single-use
The TAC PIN is a self tapping threaded wire. Its proximal part is fixed on a standard surgical power tool equipment and once the threaded wire is introduced and positioned as required, the surgeon cuts the protruding part at the bone surface. This pin is designed with a variable pitch, for a true and adapted compression. It is made out of titanium alloy, and it is delivered non sterile.
NEWDEAL
120020ND
Not in Commercial Distribution

  • 10381780052838 ()
  • M248120020ND1 ()

  • 1.6mm diam. x 20mm length
120020ND

  • Orthopaedic bone pin, non-bioabsorbable
The TAC PIN is a self tapping threaded wire. Its proximal part is fixed on a standard surgical power tool equipment and once the threaded wire is introduced and positioned as required, the surgeon cuts the protruding part at the bone surface. This pin is designed with a variable pitch, for a true and adapted compression. It is made out of titanium alloy, and it is delivered non sterile.
NEWDEAL
120025ND
Not in Commercial Distribution

  • M248120025ND1 ()
  • 10381780052845 ()

  • 1.6mm diam. x 25mm length
120025ND

  • Orthopaedic bone pin, non-bioabsorbable
The TAC PIN is a self tapping threaded wire. Its proximal part is fixed on a standard surgical power tool equipment and once the threaded wire is introduced and positioned as required, the surgeon cuts the protruding part at the bone surface. This pin is designed with a variable pitch, for a true and adapted compression. It is made out of titanium alloy, and it is delivered non sterile.
NEWDEAL
120015ND
Not in Commercial Distribution

  • M248120015ND1 ()
  • 10381780052821 ()

  • 1.6mm diam. x 15mm length
120015ND

  • Orthopaedic bone pin, non-bioabsorbable
The ATOZ Mini-Screw is intended for use as a temporary anchor for orthodontic treatment. The average implantation period of the set screw is 6 months and must be used after autoclaving by the user before use. It is also disposable and not reused. The material of the ATOZ Mini-Screw is Titanium Alloy (ASTM F136), which is widely used in dental implants, and due to the nature of the temporary screw that is removed before bone union occurs, no surface treatment is applied
MK Meditech Inc.
MKS-1615 *6EA
In Commercial Distribution

  • 08800197900686 ()


  • Orthodontic anchoring screw
The ATOZ Mini-Screw is intended for use as a temporary anchor for orthodontic treatment. The average implantation period of the set screw is 6 months and must be used after autoclaving by the user before use. It is also disposable and not reused. The material of the ATOZ Mini-Screw is Titanium Alloy (ASTM F136), which is widely used in dental implants, and due to the nature of the temporary screw that is removed before bone union occurs, no surface treatment is applied
MK Meditech Inc.
MKS-1613 *6EA
In Commercial Distribution

  • 08800197900679 ()


  • Orthodontic anchoring screw
The ATOZ Mini-Screw is intended for use as a temporary anchor for orthodontic treatment. The average implantation period of the set screw is 6 months and must be used after autoclaving by the user before use. It is also disposable and not reused. The material of the ATOZ Mini-Screw is Titanium Alloy (ASTM F136), which is widely used in dental implants, and due to the nature of the temporary screw that is removed before bone union occurs, no surface treatment is applied
MK Meditech Inc.
MKS-1613 *10EA
In Commercial Distribution

  • 08800197900662 ()


  • Orthodontic anchoring screw
The ATOZ Mini-Screw is intended for use as a temporary anchor for orthodontic treatment. The average implantation period of the set screw is 6 months and must be used after autoclaving by the user before use. It is also disposable and not reused. The material of the ATOZ Mini-Screw is Titanium Alloy (ASTM F136), which is widely used in dental implants, and due to the nature of the temporary screw that is removed before bone union occurs, no surface treatment is applied
MK Meditech Inc.
MKS-1611 *4EA
In Commercial Distribution

  • 08800197900655 ()


  • Orthodontic anchoring screw
The ATOZ Mini-Screw is intended for use as a temporary anchor for orthodontic treatment. The average implantation period of the set screw is 6 months and must be used after autoclaving by the user before use. It is also disposable and not reused. The material of the ATOZ Mini-Screw is Titanium Alloy (ASTM F136), which is widely used in dental implants, and due to the nature of the temporary screw that is removed before bone union occurs, no surface treatment is applied
MK Meditech Inc.
MKS-1611 *10EA
In Commercial Distribution

  • 08800197900648 ()


  • Orthodontic anchoring screw
The ATOZ Mini-Screw is intended for use as a temporary anchor for orthodontic treatment. The average implantation period of the set screw is 6 months and must be used after autoclaving by the user before use. It is also disposable and not reused. The material of the ATOZ Mini-Screw is Titanium Alloy (ASTM F136), which is widely used in dental implants, and due to the nature of the temporary screw that is removed before bone union occurs, no surface treatment is applied
MK Meditech Inc.
MKS-1610 *6EA
In Commercial Distribution

  • 08800197900631 ()


  • Orthodontic anchoring screw
The ATOZ Mini-Screw is intended for use as a temporary anchor for orthodontic treatment. The average implantation period of the set screw is 6 months and must be used after autoclaving by the user before use. It is also disposable and not reused. The material of the ATOZ Mini-Screw is Titanium Alloy (ASTM F136), which is widely used in dental implants, and due to the nature of the temporary screw that is removed before bone union occurs, no surface treatment is applied
MK Meditech Inc.
MKS-1611 * 8EA
In Commercial Distribution

  • 08800197900334 ()


  • Orthodontic anchoring screw
The ATOZ Mini-Screw is intended for use as a temporary anchor for orthodontic treatment. The average implantation period of the set screw is 6 months and must be used after autoclaving by the user before use. It is also disposable and not reused. The material of the ATOZ Mini-Screw is Titanium Alloy (ASTM F136), which is widely used in dental implants, and due to the nature of the temporary screw that is removed before bone union occurs, no surface treatment is applied
MK Meditech Inc.
MKS-1608
In Commercial Distribution

  • 08800197900105 ()


  • Orthodontic anchoring screw
The ATOZ Mini-Screw is intended for use as a temporary anchor for orthodontic treatment. The average implantation period of the set screw is 6 months and must be used after autoclaving by the user before use. It is also disposable and not reused. The material of the ATOZ Mini-Screw is Titanium Alloy (ASTM F136), which is widely used in dental implants, and due to the nature of the temporary screw that is removed before bone union occurs, no surface treatment is applied
MK Meditech Inc.
MKS-1610
In Commercial Distribution

  • 08800197900099 ()


  • Orthodontic anchoring screw
The ATOZ Mini-Screw is intended for use as a temporary anchor for orthodontic treatment. The average implantation period of the set screw is 6 months and must be used after autoclaving by the user before use. It is also disposable and not reused. The material of the ATOZ Mini-Screw is Titanium Alloy (ASTM F136), which is widely used in dental implants, and due to the nature of the temporary screw that is removed before bone union occurs, no surface treatment is applied
MK Meditech Inc.
MKS-1613 and MKS-1616
In Commercial Distribution

  • 08800197900310 ()


  • Orthodontic anchoring screw
The ATOZ Mini-Screw is intended for use as a temporary anchor for orthodontic treatment. The average implantation period of the set screw is 6 months and must be used after autoclaving by the user before use. It is also disposable and not reused. The material of the ATOZ Mini-Screw is Titanium Alloy (ASTM F136), which is widely used in dental implants, and due to the nature of the temporary screw that is removed before bone union occurs, no surface treatment is applied
MK Meditech Inc.
MKS-1616
In Commercial Distribution

  • 08800197900303 ()


  • Orthodontic anchoring screw
The ATOZ Mini-Screw is intended for use as a temporary anchor for orthodontic treatment. The average implantation period of the set screw is 6 months and must be used after autoclaving by the user before use. It is also disposable and not reused. The material of the ATOZ Mini-Screw is Titanium Alloy (ASTM F136), which is widely used in dental implants, and due to the nature of the temporary screw that is removed before bone union occurs, no surface treatment is applied
MK Meditech Inc.
MKS-1613
In Commercial Distribution

  • 08800197900297 ()


  • Orthodontic anchoring screw
The ATOZ Mini-Screw is intended for use as a temporary anchor for orthodontic treatment. The average implantation period of the set screw is 6 months and must be used after autoclaving by the user before use. It is also disposable and not reused. The material of the ATOZ Mini-Screw is Titanium Alloy (ASTM F136), which is widely used in dental implants, and due to the nature of the temporary screw that is removed before bone union occurs, no surface treatment is applied
MK Meditech Inc.
MKS-1611
In Commercial Distribution

  • 08800197900198 ()


  • Orthodontic anchoring screw
The ATOZ Mini-Screw is intended for use as a temporary anchor for orthodontic treatment. The average implantation period of the set screw is 6 months and must be used after autoclaving by the user before use. It is also disposable and not reused. The material of the ATOZ Mini-Screw is Titanium Alloy (ASTM F136), which is widely used in dental implants, and due to the nature of the temporary screw that is removed before bone union occurs, no surface treatment is applied
MK Meditech Inc.
MKS-1616
In Commercial Distribution

  • 08800197900136 ()


  • Orthodontic anchoring screw
The ATOZ Mini-Screw is intended for use as a temporary anchor for orthodontic treatment. The average implantation period of the set screw is 6 months and must be used after autoclaving by the user before use. It is also disposable and not reused. The material of the ATOZ Mini-Screw is Titanium Alloy (ASTM F136), which is widely used in dental implants, and due to the nature of the temporary screw that is removed before bone union occurs, no surface treatment is applied
MK Meditech Inc.
MKS-1616
In Commercial Distribution

  • 08800197900129 ()


  • Orthodontic anchoring screw
The ATOZ Mini-Screw is intended for use as a temporary anchor for orthodontic treatment. The average implantation period of the set screw is 6 months and must be used after autoclaving by the user before use. It is also disposable and not reused. The material of the ATOZ Mini-Screw is Titanium Alloy (ASTM F136), which is widely used in dental implants, and due to the nature of the temporary screw that is removed before bone union occurs, no surface treatment is applied
MK Meditech Inc.
MKS-1610 and MKS-1608
In Commercial Distribution

  • 08800197900112 ()


  • Orthodontic anchoring screw
Light A2 SmarTemp® 50ml. Cartridge
PARKELL, INC.
S340
Not in Commercial Distribution

  • M595S3400 ()
S340

  • Temporary dental crown/bridge resin
Ultralight A1 SmarTemp® Split 50ml. Cartridge
PARKELL, INC.
S337
Not in Commercial Distribution

  • M595S3370 ()
S337

  • Temporary dental crown/bridge resin
Medium A3.5 SmarTemp® 50ml. Cartridge
PARKELL, INC.
S341
Not in Commercial Distribution

  • M595S3410 ()
S341

  • Temporary dental crown/bridge resin
Dual Cure A2 (Light Shade) SmarTemp® 50ml. Cartridge
PARKELL, INC.
S338
Not in Commercial Distribution

  • M595S3380 ()
S338

  • Temporary dental crown/bridge resin
The Galileo Echo is a microprocessor-controlled instrument designed to fully automate immunohematology in vitro diagnostic testing of human blood. The Galileo Echo automates test processing, result interpretation, and data management functions. The Galileo Echo is designed to automate standard immunohematology assays using a microstrip-based platform. Assays include ABO and Rh (D) typing, detection/identification of IgG red blood cell antibodies, compatibility testing, and red blood cell phenotyping.
IMMUCOR, INC.
0087000
In Commercial Distribution

  • 10888234001584 ()
0087000

  • Immunohaematology/blood bank analyser IVD
The Galileo Neo (NEO) is a microprocessor-controlled instrument to fully automate immunohematology in vitro diagnostic testing of human blood. The NEO automates test processing, result interpretation and data management functions. The NEO is designed to automate standard immunohematology assays using a microplate-based platform. Assays include ABO grouping and Rh (D) typing, detection/identification of IgG red blood cell antibodies, compatibility testing, red blood cell phenotyping, antigen screening and infectious disease screening, such as cytomegalovirus (CMV). The antigen screening assays provide guidelines for the user to select antisera or dilute commercial blood grouping reagents as a mechanism to pre-screen for antigen negative blood units that can then be subjected to confirmation using a licensed method.
IMMUCOR, INC.
0064599
In Commercial Distribution

  • 10888234001041 ()
0064599

  • Immunohaematology/blood bank analyser IVD
The Echo Lumena is a microprocessor-controlled instrument designed to fully automate immunohematology in vitro diagnostic testing of human blood. The Echo Lumena automates test processing, result interpretation, and data management functions. The Echo Lumena is designed to automate standard immunohematology assays using a microstrip-based platform. Assays include ABO and Rh (D) typing, detection/identification of IgG red blood cell antibodies, compatibility testing, and red blood cell phenotyping.
IMMUCOR, INC.
0086998
In Commercial Distribution

  • 10888234002338 ()
0086998

  • Immunohaematology/blood bank analyser IVD
The NEO Iris is a microprocessor-controlled instrument to fully automate immunohematology in vitro diagnostic testing of human blood. The NEO Iris automates test processing, result interpretation and data management functions. The NEO Iris is designed to automate standard immunohematology assays using a microplate-based platform. Assays include ABO grouping and Rh (D) typing, detection/identification of IgG red blood cell antibodies, compatibility testing, red blood cell phenotyping and antigen screening. The NEO Iris is for in-vitro diagnostic use.
IMMUCOR, INC.
0064597
In Commercial Distribution

  • 10888234002321 ()
0064597

  • Immunohaematology/blood bank analyser IVD
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