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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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BloodTrack - 00812747010002

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

  • 00812747010002 ()


  • Clinical laboratory information system application software

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

ALYX™ 2RBC-LR Kit - 00811137010127

For Collection of Two Leukoreduced Red Blood Cell Products by Centrifugation. For Use With the ALYX™ System. Sterile Fluid Path.
FENWAL, INC.
4R5720
In Commercial Distribution

  • 10811137010124 ()
  • 00811137010127 ()
4R5720

  • Apheresis system tubing set

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

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

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

Mini Master Series - 00190746108402

DB BKT MINI MS UL CEN 022 T+24 A+3 R=0
AMERICAN ORTHODONTICS CORPORATION
310-2022
In Commercial Distribution

  • 00190746108402 ()
310-2022

  • Orthodontic bracket, metal

Mini Master Series - 00190746108396

DB BKT MINI MS UL CEN 018 T+24 A+3 R=0
AMERICAN ORTHODONTICS CORPORATION
310-2002
In Commercial Distribution

  • 00190746108396 ()
310-2002

  • Orthodontic bracket, metal

Mini Master Series - 00190746108389

DB BKT MINI MS UL CEN 022 T+24 A+3 R=0
AMERICAN ORTHODONTICS CORPORATION
310-1022
In Commercial Distribution

  • 00190746108389 ()
310-1022

  • Orthodontic bracket, metal

Mini Master Series - 00190746108372

DB BKT MINI MS UL CEN 018 T+24 A+3 R=0
AMERICAN ORTHODONTICS CORPORATION
310-1002
In Commercial Distribution

  • 00190746108372 ()
310-1002

  • Orthodontic bracket, metal

Mini Master Series - 00190746108365

DB BKT MINI MS UR CEN 022 T+24 A+3 R=0
AMERICAN ORTHODONTICS CORPORATION
310-2021
In Commercial Distribution

  • 00190746108365 ()
310-2021

  • Orthodontic bracket, metal

Mini Master Series - 00190746108358

DB BKT MINI MS UR CEN 018 T+24 A+3 R=0
AMERICAN ORTHODONTICS CORPORATION
310-2001
In Commercial Distribution

  • 00190746108358 ()
310-2001

  • Orthodontic bracket, metal

Mini Master Series - 00190746108341

DB BKT MINI MS UR CEN 022 T+24 A+3 R=0
AMERICAN ORTHODONTICS CORPORATION
310-1021
In Commercial Distribution

  • 00190746108341 ()
310-1021

  • Orthodontic bracket, metal

Mini Master Series - 00190746108334

DB BKT MINI MS UR CEN 018 T+24 A+3 R=0
AMERICAN ORTHODONTICS CORPORATION
310-1001
In Commercial Distribution

  • 00190746108334 ()
310-1001

  • Orthodontic bracket, metal

discovery® - J011722941240

discovery® smart Bracket with hook, - 7° Torque, 0° Angulation for tooth 24
DENTAURUM GmbH & Co.KG
722-941-24
In Commercial Distribution

  • J011722941240 ()
  • J011722941241 ()


  • Orthodontic bracket, metal

discovery® - J011722701240

discovery® pearl bracket, - 7° Torque, 0° Angulation for tooth 24, Roth 22
DENTAURUM GmbH & Co.KG
722-701-24
In Commercial Distribution

  • J011722701240 ()


  • Orthodontic bracket, ceramic

equilibrium® - J011722442240

equilibrium® mini Bracket with hook, - 7° Torque, 0° Angulation for tooth 24
DENTAURUM GmbH & Co.KG
722-442-24
In Commercial Distribution

  • J011722442240 ()
  • J011722442241 ()


  • Orthodontic bracket, metal

equilibrium® - J011722441240

equilibrium® mini Bracket with hook, - 7° Torque, 0° Angulation for tooth 24
DENTAURUM GmbH & Co.KG
722-441-24
In Commercial Distribution

  • J011722441240 ()
  • J011722441241 ()


  • Orthodontic bracket, metal

discovery® - J011722942240

discovery® smart Bracket with hook, - 7° Torque, 0° Angulation for tooth 24
DENTAURUM GmbH & Co.KG
722-942-24
In Commercial Distribution

  • J011722942240 ()
  • J011722942241 ()


  • Orthodontic bracket, metal

equilibrium® - J011722342240

equilibrium® 2 Bracket with hook, - 7° Torque, 0° Angulation for tooth 24
DENTAURUM GmbH & Co.KG
722-342-24
In Commercial Distribution

  • J011722342240 ()
  • J011722342241 ()


  • Orthodontic bracket, metal

equilibrium® - J011722341240

equilibrium® 2 Bracket with hook, - 7° Torque, 0° Angulation for tooth 24
DENTAURUM GmbH & Co.KG
722-341-24
In Commercial Distribution

  • J011722341240 ()
  • J011722341241 ()


  • Orthodontic bracket, metal

discovery® - J011718941240

discovery® smart Bracket with hook, - 7° Torque, 0° Angulation for tooth 24
DENTAURUM GmbH & Co.KG
718-941-24
In Commercial Distribution

  • J011718941240 ()
  • J011718941241 ()


  • Orthodontic bracket, metal

equilibrium® - J011718442240

equilibrium® mini Bracket with hook, - 7° Torque, 0° Angulation for tooth 24
DENTAURUM GmbH & Co.KG
718-442-24
In Commercial Distribution

  • J011718442240 ()
  • J011718442241 ()


  • Orthodontic bracket, metal

equilibrium® - J011718441240

equilibrium® mini Bracket with hook, - 7° Torque, 0° Angulation for tooth 24
DENTAURUM GmbH & Co.KG
718-441-24
In Commercial Distribution

  • J011718441240 ()
  • J011718441241 ()


  • Orthodontic bracket, metal

equilibrium® - J011718342240

equilibrium® 2 Bracket with hook, - 7° Torque, 0° Angulation for tooth 24
DENTAURUM GmbH & Co.KG
718-342-24
In Commercial Distribution

  • J011718342240 ()
  • J011718342241 ()


  • Orthodontic bracket, metal

equilibrium® - J011718341240

equilibrium® 2 Bracket with hook, - 7° Torque, 0° Angulation for tooth 24
DENTAURUM GmbH & Co.KG
718-341-24
In Commercial Distribution

  • J011718341240 ()
  • J011718341241 ()


  • Orthodontic bracket, metal

discovery® - J011718702240

discovery® pearl Bracket, - 7° Torque, 0° Angulation for tooth 24, McLaughlin-Bennett-Trevisi** 18
DENTAURUM GmbH & Co.KG
718-702-24
In Commercial Distribution

  • J011718702240 ()


  • Orthodontic bracket, ceramic

discovery® - J011718701240

discovery® pearl bracket, - 7° Torque, 0° Angulation for tooth 24, Roth 18
DENTAURUM GmbH & Co.KG
718-701-24
In Commercial Distribution

  • J011718701240 ()


  • Orthodontic bracket, ceramic

Hi-Rem+ # 0 - 08059388441655

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

  • 08059388443260 ()
  • 08059388441655 ()
RHP600

  • Root canal post, preformed

MISTERXRAY #0 - D9021002003

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

  • D9021002003 ()


  • Dental digital imaging sensor, intraoral

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

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

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

MOBIS 0° - 04047844001974

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

  • 04047844001974 ()

  • 16x9x28mm
BT160928

  • Polymeric spinal interbody fusion cage

MOBIS 0° - 04047844001912

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

  • 04047844001912 ()

  • 12x9x28mm
BT120928

  • Polymeric spinal interbody fusion cage

MOBIS 0° - 04047844001899

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

  • 04047844001899 ()

  • 11x9x28mm
BT110928

  • Polymeric spinal interbody fusion cage

MOBIS 0° - 04047844001875

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

  • 04047844001875 ()

  • 10x9x28mm
BT100928

  • Polymeric spinal interbody fusion cage

MOBIS 0° - 04047844001851

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

  • 04047844001851 ()

  • 9x9x28mm
BT090928

  • Polymeric spinal interbody fusion cage

MOBIS 0° - 04047844001837

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

  • 04047844001837 ()

  • 8x9x28mm
BT080928

  • Polymeric spinal interbody fusion cage
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