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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.
86-11-33
In Commercial Distribution

  • M7408610054 ()
861-0054

  • Metallic spinal interbody fusion cage
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
CYP450 2C9 drug metabolizing enzyme and VKORC1 genotyping system
AUTOGENOMICS, INC
03-3140-01
Not in Commercial Distribution

  • 00850009370181 ()
03-3140-01

  • Anticoagulant-resistance multiple genetic risk factor IVD, kit, nucleic acid technique (NAT)
CYP450 2C9 drug metabolizing enzyme and VKORC1 genotyping system
AUTOGENOMICS, INC
03-2140-01
Not in Commercial Distribution

  • 00850009370174 ()
03-2140-01

  • Anticoagulant-resistance multiple genetic risk factor IVD, kit, nucleic acid technique (NAT)
CYP450 2C9 drug metabolizing enzyme and VKORC1 genotyping system
AUTOGENOMICS, INC
03-1140-01
Not in Commercial Distribution

  • 00850009370167 ()
03-1140-01

  • Anticoagulant-resistance multiple genetic risk factor IVD, kit, nucleic acid technique (NAT)
No Description
M & T SRL
MT ONE DIAMOND
In Commercial Distribution

  • 08057622080042 ()


  • Dermatological diode laser system
  • Dermatological solid-state laser system
No Description
M & T SRL
MT ONE/D
In Commercial Distribution

  • 08057622080035 ()


  • Dermatological diode laser system
  • Dermatological solid-state laser system
  • Cosmetic red-light phototherapy system, professional
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