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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, straight
In Commercial Distribution

  • 04047844114322 ()

  • 8x9x20mm
TRT00080920

  • Metallic spinal interbody fusion cage
No Description
Drägerwerk AG & Co. KGaA
6723976
In Commercial Distribution

  • 04048675006053 ()


  • Suction system filter, microbial
Diagnostic ultrasound system
FUJIFILM SONOSITE, INC.
P31203-25
In Commercial Distribution

  • 00841517110062 ()
P31203

  • Electromechanical device/system transport trolley
Diagnostic Ultrasound Transducer
FUJIFILM SONOSITE, INC.
P32467-01
In Commercial Distribution

  • 00841517109912 ()
P32467

  • Electromechanical device/system transport trolley
Leica Biosystems Accessory
Leica Biosystems Nussloch GmbH
000000014047534612
In Commercial Distribution

  • 04049188060013 ()

  • Device Size Text, specify:
14047534612

  • Microscope slide stainer IVD
Kit Contains: CFS02, 5x100 Kii® SLEEVE ADVFIX 12/BX CD003, 5mm RETRIEVAL SYSTEM, 10/BX CA500, EPIX® UNIVERSAL CLIP APPLIER 3/BX CFB12, 5x100 Kii® SH BLD ADVFIX DP 10/BX
APPLIED MEDICAL RESOURCES CORPORATION
K2293
In Commercial Distribution

  • 30607915128983 ()


  • Tissue extraction bag
  • Laparoscopic access cannula, single-use
  • Ligation clip, metallic
The Bilok® ST Screw is a cannulated, sterile, single-use bone screw made of an absorbable Poly (L-lactic) acid and calcium phosphate which will gradually be absorbed into the body over a period of 24 months. This function however is patient dependant. The Bilok® ST Screw is for use as a fixation screw in cruciate ligament surgery. It provides a combination of suspension and compression fixation that resorbs and it is subsequently replaced with bone during the healing process. Bilok® ST Screw is biodegradable and biocompatible.
BIOCOMPOSITES LTD
160-930ST
Not in Commercial Distribution

  • 50601557104958 ()

  • Length: 30 Millimeter
  • Width: 9 Millimeter
160-930ST

  • Bioabsorbable orthopaedic bone screw
No Description
HIOSSEN, INC.
ETFSA701SHW
In Commercial Distribution

  • 00810019240959 ()


  • Screw endosteal dental implant, two-piece
No Description
HIOSSEN, INC.
ETFSA603SHW
In Commercial Distribution

  • 00810019240935 ()


  • Screw endosteal dental implant, two-piece
No Description
HIOSSEN, INC.
ETFSAS503SNW
In Commercial Distribution

  • 00810019240867 ()


  • Screw endosteal dental implant, two-piece
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