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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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Tethys H10 is intended only for the washing and/or thermal disinfection of re-usable surgical instruments able to resist to a temperature of at least 80°C.
CEFLA SOCIETA' COOPERATIVA
Tethys H10
In Commercial Distribution

  • 08033837931331 ()
M7E200310

  • Ultrasonic-cleaning water bath
  • Surgical utensil washer/disinfector
DASH Pod
Insulet Corporation
POD-BLE-11-520
In Commercial Distribution

  • 20385082000020 ()
  • 10385082000023 ()
  • 10385082000023 ()
  • 20385082000051 ()


  • Ambulatory insulin infusion pump, electronic
OCS Mobile Base
TRANSMEDICS, INC.
1411
In Commercial Distribution

  • B00925711 ()
  • B00913320 ()

  • Height: 10 Inch
  • Width: 28 Inch
  • Length: 21 Inch
1411

  • Utility trolley
Phosphate Buffered Saline (PBS), 1.0ml, 13x100mm tube, optically clear, shatter resistant, polycarbonate tube, order by the package of 20 Hardy Diagnostics Phosphate Buffered Saline (pH of 7.5) is recommended as a diluent for quantitative culturing or as a rinsing agent in microbiological, immunological, histological and molecular testing procedures.
HARDY DIAGNOSTICS
R201
In Commercial Distribution

  • 00819398023184 ()
  • 00819398023191 ()
R201

  • Buffered sample diluent IVD, manual
Disposable Reflective Spheres attached to reference frames and surgical instruments for use during surgical navigation in image guided surgery. One retail carton is made up of 1 sphere per inner pouch with 4 inner pouches in an outer pouch. There are 5 pouch-in-pouches for a total of 20 spheres.
Northern Digital Inc
8800739
In Commercial Distribution

  • 20805832040033 ()
  • 00805832040039 ()
8800739

  • Imaging lesion localization marker, external, single-use
No Description
BIOMET SPINE LLC
14-524506
In Commercial Distribution

  • 00888480609247 ()

  • LINEUM 4.0MM X 6MM CC SCREW TRANSLATING SCREW LINEUM OCT SPINE SYSTEM
14-524506

  • Bone-screw internal spinal fixation system, non-sterile
Kit Contains: CA090, DIRECT DRIVE® LCA 3/BX C2201, 120MM INSUFF NEEDLE XE, 20/BX CTF03, 5x100 Kii® Fios® Z-THR 6/BX CTF33, 11x100 Kii® Fios® ZTHR 6/BX CTB33, 11X100 Kii® SH BLD ZTHR 6/BX CY010, 5mmX35cm EPIX® LAPA DISSECT, 10/BX
APPLIED MEDICAL RESOURCES CORPORATION
K2818
In Commercial Distribution

  • 30607915135288 ()


  • Laparoscopic electrosurgical blunt dissector
  • Laparoscopic access cannula, single-use
  • Spring-loaded pneumoperitoneum needle, single-use
  • Ligation clip, metallic
Kit Contains: CA090, DIRECT DRIVE® LCA 3/BX C2201, 120MM INSUFF NEEDLE XE, 20/BX CTF03, 5x100 Kii® Fios® Z-THR 6/BX CTF33, 11x100 Kii® Fios® ZTHR 6/BX CTB33, 11X100 Kii® SH BLD ZTHR 6/BX C6001, 5mmX33cm PROB/VALV DUAL BAG 12/BX
APPLIED MEDICAL RESOURCES CORPORATION
K2820
In Commercial Distribution

  • 30607915135257 ()


  • Laparoscopic irrigation/aspiration cannula
  • Laparoscopic access cannula, single-use
  • Spring-loaded pneumoperitoneum needle, single-use
  • Ligation clip, metallic
Kit Contains: CA090, DIRECT DRIVE® LCA 3/BX C2201, 120MM INSUFF NEEDLE XE, 20/BX C4130, 5mmx35cm EPIX® LAPA GRASPER, 10/BX CTF03, 5x100 Kii® Fios® Z-THR 6/BX CTF33, 11x100 Kii® Fios® ZTHR 6/BX CB030, 5mmx35cm EPIX® LAPA SCISSOR, 10/BX
APPLIED MEDICAL RESOURCES CORPORATION
K0456
In Commercial Distribution

  • 30607915127115 ()


  • Endoscopic electrosurgical handpiece/electrode, monopolar, single-use
  • Laparoscopic access cannula, single-use
  • Rigid endoscopic grasping forceps, single-use
  • Spring-loaded pneumoperitoneum needle, single-use
  • Ligation clip, metallic
Kit Contains: C2201, 120MM INSUFF NEEDLE XE, 20/BX CTF73, 12x100 Kii Fios ZTHR 6/BX CTB73, 12x100 Kii SH BLD ZTHR 6/BX CTF03, 5x100 Kii Fios Z-THR 6/BX C6001, 5mmX33cm PROB/VALV DUAL BAG 12/BX CA090, DIRECT DRIVE LCA 3/BX CD001, 10mm RETRIEVAL SYSTEM, 10/BX
APPLIED MEDICAL RESOURCES CORPORATION
GK222
In Commercial Distribution

  • 20607915130712 ()


  • Tissue extraction bag
  • Laparoscopic irrigation/aspiration cannula
  • Laparoscopic access cannula, single-use
  • Spring-loaded pneumoperitoneum needle, single-use
  • Ligation clip, metallic
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