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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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MLB 2 - 07611969965731

Modified LISS-Enhancement media for TANGO instruments and tube test; 50 ml
Bio-Rad Medical Diagnostics GmbH
805200100
In Commercial Distribution

  • 07611969965731 ()
805200100

  • Low ionic-strength salt solution (LISS) immunohaematology reagent IVD

MLB 2 - 07611969950898

Modified LISS-Enhancement media for TANGO instruments and tube test; 50 ml
Bio-Rad Medical Diagnostics GmbH
805200100
In Commercial Distribution

  • 07611969950898 ()
805200100

  • Low ionic-strength salt solution (LISS) immunohaematology reagent IVD

NexLynk DMS - 00812747010187

NexLynk DMS version 4.x.x
HAEMONETICS CORPORATION
4.x.x
In Commercial Distribution

  • 00812747010187 ()


  • Blood bank information system application software

SafeTrace Tx - 00812747010101

SafeTrace Tx version 3.x.x
HAEMONETICS CORPORATION
3.x.x
In Commercial Distribution

  • 00812747010101 ()


  • Blood bank information system application software

BloodTrack - 00812747010002

BloodTrack version 4.x.x
HAEMONETICS CORPORATION
4.x.x
In Commercial Distribution

  • 00812747010002 ()


  • Clinical laboratory information system application software

Celling ART PRP 2-Step Mini Kit - 00817771028870

ART PRP 2-Step Processing Kit - Mini - w/o blood draw
Celling Biosciences
1651-0002
In Commercial Distribution

  • 00817771028870 ()
1651-0002

  • Haematological concentrate system preparation kit, platelet concentration

Celling ART PRP 2-Step 120 Kit - 00817771028856

ART PRP 2-Step Processing Kit - 120
Celling Biosciences
1651-0005
In Commercial Distribution

  • 00817771028856 ()
1651-0005

  • Haematological concentrate system preparation kit, platelet concentration

Celling ART PRP 2-Step 60 Kit - 00817771028825

ART PRP 2-Step Processing Kit - 60
Celling Biosciences
1651-0004
In Commercial Distribution

  • 00817771028825 ()
1651-0004

  • Haematological concentrate system preparation kit, platelet concentration

HAEMONETICS PCS 2 APHERESIS SYSTEM - 30812747011970

PCS2, LIST NO,06002-110-EXP-EW
HAEMONETICS CORPORATION
06002-110-EXP-EW
In Commercial Distribution

  • 30812747011970 ()


  • Autotransfusion system blood component processing set

Trackit - 05060275450257

No Description
LIFELINES LIMITED
Trackit 24/0 Kit
In Commercial Distribution

  • 05060275450257 ()
2123B

  • Electroencephalographic ambulatory recorder

STAT PROFILE - 00385480451505

Prime Auto QC Cartridge CCS 200 Sample
NOVA BIOMEDICAL CORPORATION
PRIME CCS
In Commercial Distribution

  • 00385480451505 ()
45150

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, control

STAT PROFILE - 00385480306461

STAT PROFILE PHOX PLUS/C CONTROLS AUTO-CARTRIDGE, 330
NOVA BIOMEDICAL CORPORATION
PHOX PLUS/C
In Commercial Distribution

  • 00385480306461 ()
30646

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, control

STAT PROFILE - 00385480306454

STAT PROFILE PHOX PLUS/C CONTROLS AUTO-CARTRIDGE, 220
NOVA BIOMEDICAL CORPORATION
PHOX PLUS/C
In Commercial Distribution

  • 00385480306454 ()
30645

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, control

STAT PROFILE - 00385480306447

STAT PROFILE PHOX PLUS/C CONTROLS AUTO-CARTRIDGE, 110
NOVA BIOMEDICAL CORPORATION
PHOX PLUS/C
In Commercial Distribution

  • 00385480306447 ()
30644

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, control

STAT PROFILE - 00385480306430

STAT PROFILE PHOX PLUS/C CONTROLS AUTO-CARTRIDGE, 75
NOVA BIOMEDICAL CORPORATION
PHOX PLUS/C
In Commercial Distribution

  • 00385480306430 ()
30643

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, control

STAT PROFILE - 00385480278966

STAT PROFILE pHOx PLUS/C CONTROL 1,2,3
NOVA BIOMEDICAL CORPORATION
phox plus/c
In Commercial Distribution

  • 00385480278966 ()
  • 00385489278967 ()
27896

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, control

STAT PROFILE - 00385480356381

STAT PROFILE CRITICAL CARE XPRESS CONTROL 1,2,3
NOVA BIOMEDICAL CORPORATION
CCX
In Commercial Distribution

  • 00385480356381 ()
  • 00385489356382 ()
35638

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, control

STAT PROFILE - 00385480341172

STAT PROFILE pHOx PLUS L CONTROL 1,2,3
NOVA BIOMEDICAL CORPORATION
phox plus L
In Commercial Distribution

  • 00385480341172 ()
  • 00385489341173 ()
34117

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, control

STAT PROFILE - 00385480340939

Stat Profile pHOx Plus L Controls Auto-Cartridge, 110
NOVA BIOMEDICAL CORPORATION
PHOX PLUS L
In Commercial Distribution

  • 00385480340939 ()
34093

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, control

STAT PROFILE - 00385480340922

Stat Profile pHOx Plus L Controls Auto-Cartridge, 220
NOVA BIOMEDICAL CORPORATION
PHOX PLUS L
In Commercial Distribution

  • 00385480340922 ()
34092

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, control

STAT PROFILE - 00385480340915

Stat Profile pHOx Plus L Controls Auto-Cartridge, 330
NOVA BIOMEDICAL CORPORATION
PHOX PLUS L
In Commercial Distribution

  • 00385480340915 ()
34091

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, control

STAT PROFILE - 00385480340908

Stat Profile pHOx Plus L Controls Auto-Cartridge, 75
NOVA BIOMEDICAL CORPORATION
PHOX PLUS L
In Commercial Distribution

  • 00385480340908 ()
34090

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, control

STAT PROFILE - 00385480239332

STAT PROFILE PHOX/BASIC CONTROLS AUTO-CARTRIDGE,330
NOVA BIOMEDICAL CORPORATION
PHOX/BASIC
In Commercial Distribution

  • 00385480239332 ()
23933

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, control

STAT PROFILE - 00385480239325

STAT PROFILE PHOX/BASIC CONTROLS AUTO-CARTRIDGE,220
NOVA BIOMEDICAL CORPORATION
PHOX/BASIC
In Commercial Distribution

  • 00385480239325 ()
23932

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, control

STAT PROFILE - 00385480239318

STAT PROFILE PHOX/BASIC CONTROLS AUTO-CARTRIDGE,110
NOVA BIOMEDICAL CORPORATION
PHOX/BASIC
In Commercial Distribution

  • 00385480239318 ()
23931

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, control

STAT PROFILE - 00385480239301

STAT PROFILE PHOX/BASIC CONTROLS AUTO-CARTRIDGE,75
NOVA BIOMEDICAL CORPORATION
PHOX/BASIC
In Commercial Distribution

  • 00385480239301 ()
23930

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, control

STAT PROFILE - 00385480227636

STAT PROFILE pHOx/BASIC CONTROL 1,2,3
NOVA BIOMEDICAL CORPORATION
phox/basic
In Commercial Distribution

  • 00385480227636 ()
  • 00385489227637 ()
22763

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, control

STAT PROFILE - 00385480489355

Stat Profile pHOx Ultra/CCX Blood Gas Controls Multipack L1, 2, 3 (Amps)
NOVA BIOMEDICAL CORPORATION
phox ultra/ccx
In Commercial Distribution

  • 00385480489355 ()
  • 00385489489356 ()
48935

  • Assisted reproduction centrifuge tube

STAT PROFILE - 00385480489041

Stat Profile pHOx Ultra/CCX Blood Gas Controls Auto-Cartridge 9/Day
NOVA BIOMEDICAL CORPORATION
PHOX ULTRA/CCX
In Commercial Distribution

  • 00385480489041 ()
48904

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, control

STAT PROFILE - 00385480489034

Stat Profile pHOx Ultra/CCX Blood Gas Controls Auto-Cartridge 6/Day
NOVA BIOMEDICAL CORPORATION
PHOX ULTRA/CCX
In Commercial Distribution

  • 00385480489034 ()
48903

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, control

MISTERXRAY #0 - D9021002003

No Description
Dental Savings Club Inc
Mister-X-#0
In Commercial Distribution

  • D9021002003 ()


  • Dental digital imaging sensor, intraoral

Xenoscope 0° - 00854490007007

Xenoscope, 0°, 10mm x 36 cm
XENOCOR, INC.
XS-0-1036
In Commercial Distribution

  • 00854490007007 ()
XS-0-1036

  • Rigid video laparoscope
  • Rigid-tip video laparoscope/thoracoscope, reusable

Hi-Rem+ # 0 - 08059388441655

No Description
OVERFIBERS SRL
Hi-Rem+ # 0
In Commercial Distribution

  • 08059388443260 ()
  • 08059388441655 ()
RHP600

  • Root canal post, preformed

TETRIS 0° - 04047844018422

The basic shape of the KIMBA®, KIMBA® mini, MOBIS®, NOVAL™, SEMIAL®, PEEK TETRIS™ and Titanium TETRIS™devices is a hollow structural frame. The upper and lower aspects of the implant are open. Surface spikes assist in the positive anchorage and seating of the implant between the vertebral bodies. The device is available in a variety of sizes enabling the surgeon to choose the size best suited to the individual pathology and anatomical condition.
SIGNUS Medizintechnik GmbH
Lumbar cage, straight
In Commercial Distribution

  • 04047844018422 ()

  • 13x11x20mm
TK131120

  • Polymeric spinal interbody fusion cage

TETRIS 0° - 04047844002315

The basic shape of the KIMBA®, KIMBA® mini, MOBIS®, NOVAL™, SEMIAL®, PEEK TETRIS™ and Titanium TETRIS™devices is a hollow structural frame. The upper and lower aspects of the implant are open. Surface spikes assist in the positive anchorage and seating of the implant between the vertebral bodies. The device is available in a variety of sizes enabling the surgeon to choose the size best suited to the individual pathology and anatomical condition.
SIGNUS Medizintechnik GmbH
Lumbar cage, straight
In Commercial Distribution

  • 04047844002315 ()

  • 7x9x24mm
TK070924

  • Polymeric spinal interbody fusion cage

TETRIS 0° - 04047844002308

The basic shape of the KIMBA®, KIMBA® mini, MOBIS®, NOVAL™, SEMIAL®, PEEK TETRIS™ and Titanium TETRIS™devices is a hollow structural frame. The upper and lower aspects of the implant are open. Surface spikes assist in the positive anchorage and seating of the implant between the vertebral bodies. The device is available in a variety of sizes enabling the surgeon to choose the size best suited to the individual pathology and anatomical condition.
SIGNUS Medizintechnik GmbH
Lumbar cage, straight
In Commercial Distribution

  • 04047844002308 ()

  • 6x11x20mm
TK061120

  • Polymeric spinal interbody fusion cage

MOBIS 0° - 04047844002292

The KIMBA®, KIMBA® mini, MOBIS® and NOVAL™ implants have a hollow, slightly curved frame with tapered edges. The frame is made from PEEK-OPTIMA®. SEMIAL® spinal implants have a semi-cylindrical form and are hollow. The implant is made from PEEK-OPTIMA®. The provision of varying heights, together with a wedge shaped option, allow better lordosis control. The TETRIS® implants (PEEK and Titanium) are hollow having a rectangular frame with lateral fenestrations. The upper and lower aspects of the implant are open and the walls feature spikes which assist in the positive anchorage and seating of the implant between the superior and inferior vertebral bodies. These implants are available in a variety of dimensional and angular sizes. This enables the surgeon to choose the size suited to the individual pathology and anatomy and condition. The MOBIS, NOVAL, SEMIAL and PEEK TETRIS devices are manufactured from polyetheretherketone (PEEK-OPTIMA® LT1, Invibio™) as described by ASTM F2026. Integral marker pins are manufactured from titanium alloy (Ti-6Al-4V) as described by ASTM F136 / ISO 5832-3 or tantalum as described by ASTM F560. The Titanium TETRIS devices are manufactured from titanium alloy (Ti-6Al-4V) as described by ASTM F136 / ISO 5832-3. The KIMBA® and KIMBA® mini devices are manufactured from ECF PEEK OPTIMA (Invibio™).
SIGNUS Medizintechnik GmbH
Lumbar cage, straight
In Commercial Distribution

  • 04047844002292 ()

  • 6x9x28mm
BT060928

  • Polymeric spinal interbody fusion cage

TETRIS 0° - 04047844002285

The basic shape of the KIMBA®, KIMBA® mini, MOBIS®, NOVAL™, SEMIAL®, PEEK TETRIS™ and Titanium TETRIS™devices is a hollow structural frame. The upper and lower aspects of the implant are open. Surface spikes assist in the positive anchorage and seating of the implant between the vertebral bodies. The device is available in a variety of sizes enabling the surgeon to choose the size best suited to the individual pathology and anatomical condition.
SIGNUS Medizintechnik GmbH
Lumbar cage, straight
In Commercial Distribution

  • 04047844002285 ()

  • 24x11x20mm
TK241120

  • Polymeric spinal interbody fusion cage

TETRIS 0° - 04047844002278

The basic shape of the KIMBA®, KIMBA® mini, MOBIS®, NOVAL™, SEMIAL®, PEEK TETRIS™ and Titanium TETRIS™devices is a hollow structural frame. The upper and lower aspects of the implant are open. Surface spikes assist in the positive anchorage and seating of the implant between the vertebral bodies. The device is available in a variety of sizes enabling the surgeon to choose the size best suited to the individual pathology and anatomical condition.
SIGNUS Medizintechnik GmbH
Lumbar cage, straight
In Commercial Distribution

  • 04047844002278 ()

  • 20x11x20mm
TK201120

  • Polymeric spinal interbody fusion cage

MOBIS 0° - 04047844001998

The KIMBA®, KIMBA® mini, MOBIS® and NOVAL™ implants have a hollow, slightly curved frame with tapered edges. The frame is made from PEEK-OPTIMA®. SEMIAL® spinal implants have a semi-cylindrical form and are hollow. The implant is made from PEEK-OPTIMA®. The provision of varying heights, together with a wedge shaped option, allow better lordosis control. The TETRIS® implants (PEEK and Titanium) are hollow having a rectangular frame with lateral fenestrations. The upper and lower aspects of the implant are open and the walls feature spikes which assist in the positive anchorage and seating of the implant between the superior and inferior vertebral bodies. These implants are available in a variety of dimensional and angular sizes. This enables the surgeon to choose the size suited to the individual pathology and anatomy and condition. The MOBIS, NOVAL, SEMIAL and PEEK TETRIS devices are manufactured from polyetheretherketone (PEEK-OPTIMA® LT1, Invibio™) as described by ASTM F2026. Integral marker pins are manufactured from titanium alloy (Ti-6Al-4V) as described by ASTM F136 / ISO 5832-3 or tantalum as described by ASTM F560. The Titanium TETRIS devices are manufactured from titanium alloy (Ti-6Al-4V) as described by ASTM F136 / ISO 5832-3. The KIMBA® and KIMBA® mini devices are manufactured from ECF PEEK OPTIMA (Invibio™).
SIGNUS Medizintechnik GmbH
Lumbar cage, straight
In Commercial Distribution

  • 04047844001998 ()

  • 18x9x28mm
BT180928

  • Polymeric spinal interbody fusion cage
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