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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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Dilator One
SPINEOLOGY INC.
67-08-06
In Commercial Distribution

  • M7406710052 ()
671-0052

  • Laparoscopic access cannula dilator
Dilator One
SPINEOLOGY INC.
33-08-02
In Commercial Distribution

  • M7403120014 ()
312-0014

  • Laparoscopic access cannula dilator
Dilator One
SPINEOLOGY INC.
53-07-11
In Commercial Distribution

  • M7405300012 ()
530-0012

  • Laparoscopic access cannula dilator
Contents: One SpermSelect System and one TheCurve
Coopersurgical, Inc.
SM603-F
In Commercial Distribution

  • 60888937003644 ()


  • Spermatozoa/semen motility medium supplement
Contents: one SpermSelect System and one MiniSpace
Coopersurgical, Inc.
SM601-F
In Commercial Distribution

  • 60888937003620 ()


  • Spermatozoa/semen motility medium supplement
MEDICAL DEVICE, UDI LABEL PLACEMENT, OEC One ASD
GE Hualun Medical Systems Co., Ltd
One ASD
In Commercial Distribution

  • 00195278685001 ()


  • Mobile general-purpose fluoroscopic x-ray system, digital
TENS One is a TENS device which is commonly used to provide relief from pain associated with sore or aching muscles of the lower back, arms, or legs due to strain from exercise or normal household and work activities. It has 3 treatment modes and is designed to be easy to use, with analog-style rotary intensity controls, digital mode selection and display, open circuit detection and keypad cover. It uses standard AA batteries and self-adhesive electrode pads. Garment glove and sock electrodes are available as optional extras.
TENSCARE LIMITED
TENS One
In Commercial Distribution

  • 05033435134045 ()
K-TENSONE

  • Analgesic transcutaneous electrical nerve stimulation system
IBA Proton Therapy System – Proteus 235
Ion Beam Applications SA
Proteus ONE
In Commercial Distribution

  • 05404013821303 ()


  • Proton therapy system
IBA Proton Therapy System – Proteus 235
Ion Beam Applications SA
Proteus ONE
In Commercial Distribution

  • 05404013820504 ()


  • Proton therapy system
Intraoral Optical Scanning System
Ori Inc
Ori One
In Commercial Distribution

  • 00860008859501 ()
10000

  • Intraoral optical scanning system
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