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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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OvuSense - 05060508530039

M300 OvuCore Starter Pack - M026 OvuCore Vaginal Sensor and M032 OvuSense App
VIO HEALTHTECH LIMITED
M300
In Commercial Distribution

  • 05060508530039 ()


  • Thermometric fertility analyser

STERILE ROBOT ARM INTERFACE - 03760244030436

Robot Arm Interface instrument Rosa 3.0 instrument ROSA One spine app 3.1
MEDTECH
ROSA3-048A
Not in Commercial Distribution

  • 03760244030436 ()
ROSAS00126

  • Neurological stereotactic surgery system
  • Multi-purpose stereotactic surgery system

BIOMET - 00815634020283

RIGID ENDOSCOPIC AEROSOL APP. 5MM DIA X 40CM (16 IN) 1:1
Micromedics, Inc.
800-0217
In Commercial Distribution

  • 00815634020283 ()
  • 10815634020280 ()
  • 20815634020287 ()


  • Open-surgery adhesive/sealant applicator, dual-channel

Spacelabs Healthcare - 10841522126079

10 LD PNT CBL PINCH CC/VOYAGER
SPACELABS HEALTHCARE (WASHINGTON), INC
CCOLLECT; CDIRECT; PXCABLES; CD12USB
In Commercial Distribution

  • 10841522126079 ()
25-0021

  • Electrical-only medical device connection cable, reusable

Tornado™ - 10840642168709

Bioactive Bone Matrix, 5 cc Moldable Strip
Spine Wave, Inc.
11-5805
In Commercial Distribution

  • 10840642168709 ()

  • 5 cc


  • Bone matrix implant, animal-derived, bioabsorbable

IRISpec - 10837461002680

IRISPEC CA/CB/CC URINE CHEMISTRY CONTROLS
BECKMAN COULTER IRELAND INC.
CA/CB/CC URINE CHEMSITRY CONTROLS
In Commercial Distribution

  • 10837461002680 ()
800-7702

  • Multiple urine analyte IVD, control

IRISpec - 10837461002611

IRISPEC CA/CB/CC URINE CHEMISTRY CONTROLS
BECKMAN COULTER IRELAND INC.
CA/CB/CC URINE CHEMSITRY CONTROLS
In Commercial Distribution

  • 10837461002611 ()
800-7211

  • Multiple urine analyte IVD, control

GEN2 - 00840343726102

CC SPINAL CURETTE STR 13'' 2-0 GOLD
SURGIX MEDICAL LLC
G2N87452
In Commercial Distribution

  • 00840343726102 ()

  • Length: 13 Inch
  • Tip Size 2-0
G2N87452

  • Bone curette, reusable

GEN2 - 00840343714505

CC SPINAL CURETTE REV ANG 10" 5-0
SURGIX MEDICAL LLC
G2N87437
In Commercial Distribution

  • 00840343714505 ()

  • Length: 10 Inch
  • Tip Width 5MM
  • Direction - Rev Ang
G2N87437

  • Bone curette, reusable

Medicrea|UNiD MIS - 03613720290254

UNID EXP B33256099-02 CC PERC 6.0 4UPL
MEDICREA INTERNATIONAL
B33256099-02
In Commercial Distribution

  • 03613720290254 ()


  • Bone-screw internal spinal fixation system rod
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