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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 SIGNUS TETRIS™ ST and SIGNUS TETRIS™ R ST system is an intervertebral fusion device to treat degenerative disc disease. The implants are additively manufactured from titanium alloy (Ti-6Al-4V). Each device is available in a single footprint, with multiple heights and angulations. The SIGNUS TETRIS™ ST/ TETRIS™ R ST device is placed by a PLIF (Posterior Lumbar Interbody Fusion) approach in the L2 – S1 spinal region and should be inserted in pairs. The device is comprised of structural titanium in an open-pore grid structure. The large fenestration in the implant permits the cage to be packed with autogenous bone graft and/or allograft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion.
SIGNUS Medizintechnik GmbH
Lumbar cage, angled
In Commercial Distribution

  • 04047844113257 ()

  • 15x10x24mm
TST20151024

  • Metallic spinal interbody fusion cage
The SIGNUS TETRIS™ ST and SIGNUS TETRIS™ R ST system is an intervertebral fusion device to treat degenerative disc disease. The implants are additively manufactured from titanium alloy (Ti-6Al-4V). Each device is available in a single footprint, with multiple heights and angulations. The SIGNUS TETRIS™ ST/ TETRIS™ R ST device is placed by a PLIF (Posterior Lumbar Interbody Fusion) approach in the L2 – S1 spinal region and should be inserted in pairs. The device is comprised of structural titanium in an open-pore grid structure. The large fenestration in the implant permits the cage to be packed with autogenous bone graft and/or allograft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion.
SIGNUS Medizintechnik GmbH
Lumbar cage, angled
In Commercial Distribution

  • 04047844113240 ()

  • 14x10x24mm
TST20141024

  • Metallic spinal interbody fusion cage
The SIGNUS TETRIS™ ST and SIGNUS TETRIS™ R ST system is an intervertebral fusion device to treat degenerative disc disease. The implants are additively manufactured from titanium alloy (Ti-6Al-4V). Each device is available in a single footprint, with multiple heights and angulations. The SIGNUS TETRIS™ ST/ TETRIS™ R ST device is placed by a PLIF (Posterior Lumbar Interbody Fusion) approach in the L2 – S1 spinal region and should be inserted in pairs. The device is comprised of structural titanium in an open-pore grid structure. The large fenestration in the implant permits the cage to be packed with autogenous bone graft and/or allograft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion.
SIGNUS Medizintechnik GmbH
Lumbar cage, angled
In Commercial Distribution

  • 04047844113233 ()

  • 13x10x24mm
TST20131024

  • Metallic spinal interbody fusion cage
TORQUE MASTER 20 4-HOLE IS AN ADJUSTABLE SPEED UP TO 20000 RPM LOW SPEED PNEUMATIC DENTAL MOTOR, USED IN CONJUNCTION WITH OTHER ATTACHMENTS SUCH AS BURS AND MANDRELS WHICH CONNECTS TO AN OPERATORY TO DRILL BONE, TEETH AND TOUGH TISSUES IN A DENTAL SETTING. REMOVING CALCULUS AND POLISHING TEEETH
MTI Precision Products, LLC
TM204
In Commercial Distribution

  • D826TM2040 ()
  • D826TM204 ()


  • Dental surgical power tool motor, pneumatic
TORQUE MASTER 20 2-HOLE IS AN ADJUSTABLE SPEED UP TO 20000 RPM LOW SPEED PNEUMATIC DENTAL MOTOR, USED IN CONJUNCTION WITH OTHER ATTACHMENTS SUCH AS BURS AND MANDRELS WHICH CONNECTS TO AN OPERATORY TO DRILL BONE, TEETH AND TOUGH TISSUES IN A DENTAL SETTING. REMOVING CALCULUS AND POLISHING TEEETH
MTI Precision Products, LLC
TM202
In Commercial Distribution

  • D826TM2020 ()
  • D826TM202 ()


  • Dental surgical power tool motor, pneumatic
No Description
SAMSUNG MEDISON CO., LTD.
USP-CZ24EAA/WR
In Commercial Distribution

  • 08806167740122 ()


  • Extracorporeal ultrasound imaging transducer, hand-held
Leica Biosystems Accessory
Leica Biosystems Nussloch GmbH
000000014047534516
In Commercial Distribution

  • 04049188060204 ()

  • Device Size Text, specify:
14047534516

  • Microscope slide stainer IVD
No Description
BIOANALYTIC GmbH, biomed. Analysentechnik
003605-6005
In Commercial Distribution

  • 04061609000033 ()
  • 04061609000552 ()


  • Sperm concentration indicator IVD, reagent
For microscopic counting of Sperms. (5 Tests)
BIOANALYTIC GmbH, biomed. Analysentechnik
003604-6005
In Commercial Distribution

  • 04061609000019 ()
  • 04061609000545 ()


  • Sperm concentration indicator IVD, reagent
20 GA/5000 CPM; Vitrectomy Pak
Alcon Laboratories, Inc.
8065751020
In Commercial Distribution

  • 10380657510204 ()
  • 00380657510207 ()

  • 20 Gauge


  • Vitrectomy system handpiece
2-0 Pdo 14x14
Surgical Specialties México, S. de R.L. de C.V.
RA-1086Q
In Commercial Distribution

  • 10848782019271 ()
  • 00848782019274 ()

  • 2-0 USP


  • Polyester suture, bioabsorbable, monofilament, non-antimicrobial
No Description
BIOCARE MEDICAL LLC
OPAI062T60
In Commercial Distribution

  • 00847627024428 ()


  • Cytokeratin IVD, antibody
No Description
BIOCARE MEDICAL LLC
NPAI062T80
In Commercial Distribution

  • 00847627039002 ()


  • Cytokeratin IVD, antibody
No Description
BIOCARE MEDICAL LLC
NPAI062T40
In Commercial Distribution

  • 00847627038999 ()


  • Cytokeratin IVD, antibody
CA and HP are intended to transmit and apply the mechanical energy produced by a dental air or electric micromotor. They contain the gearing necessary for maintaining, increasing or reducing the micromotor's speed
Bien-Air Dental SA
1600632-001
In Commercial Distribution

  • J00716006320011 ()
1600632-001

  • Dental power tool system handpiece, remotely-driven
This is a medical device.The dental treatment unit running as a desktop unit is intended for use in the field of dentistry. It is designed for the operation of an electrically operated small voltage motor. Area of application is in the field of endodontics and tooth preparation. The ELECTROmatic is intended to convert pneumatic output from a dental treatment center to electrical energy for operation of electrically-driven dental handpieces. This device is designed for use by a trained professional in the field of general dentistry.The ELECTROmatic dental control unit is a stand-alone system for operating electrically-driven KaVo handpieces. External power supply provides electric power to the unit. The 4-hole tubing connected to the unit supplies chip /cooling air, water and pressure signal. The speed of the electric handpiece is controlled by air pressure. The control unit is positioned close to a treatment unit at thelocation preferred by the dentist. The ELECTROmatic system consists of a base unit with a motor hose, an electrical motor, a transformer, and a power cord. The dental treatment unit running as a desktop unit is intended for use in the field of dentistry. It is designed for the operation of an electrically operated small voltage motor. Area of application is in the field of endodontics and tooth preparation. The ELECTROmatic is intended to convert pneumatic output from a dental treatment center to electrical energy for operation of electrically-driven dental handpieces. This device is designed for use by a trained professional in the field of general dentistry.
KaVo Dental GmbH
1.003.1107
In Commercial Distribution

  • EKAV100311070 ()
20 E

  • Dental power tool system handpiece, line-powered
No Description
BIOCARE MEDICAL LLC
CM062C
In Commercial Distribution

  • 00847627005830 ()


  • Cytokeratin IVD, antibody
No Description
BIOCARE MEDICAL LLC
CM062A
In Commercial Distribution

  • 00847627005823 ()


  • Cytokeratin IVD, antibody
No Description
Dynarex Corporation
4140
In Commercial Distribution

  • 00616784414010 ()
  • 00616784414027 ()
  • 00616784414034 ()


  • Manual scalpel blade, single-use
No Description
BIOCARE MEDICAL LLC
IP062G10
In Commercial Distribution

  • 00847627008541 ()


  • Cytokeratin IVD, antibody
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