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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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0.35mm x 2.0cm VISICOIL MR Platinum loaded in an 22 gauge 15cm pre-waxed brachytherapy needle.
Izi Medical Products, LLC
SNMR-035-020-2215
In Commercial Distribution

  • EIBASNMR03502022150 ()
SNMR-035-020-2215

  • Radiological image marker, implantable
0.35mm x 1.0cm VISICOIL MR Platinum loaded in an 22 gauge 15cm pre-waxed brachytherapy needle.
Izi Medical Products, LLC
SNMR-035-010-2215
In Commercial Distribution

  • EIBASNMR03501022150 ()
SNMR-035-010-2215

  • Radiological image marker, implantable
BANDITT SINUS KIT includes: SIN1, SIN2, SIN3, SIN4, SIN5 in a 5 piece cassette #7501
Terlain Enterprises, Inc.
SINKIT
In Commercial Distribution

  • D955SINKIT1 ()


  • Periosteal elevator, reusable
DI divert-to-drain used in a water purification system for dialysis applications. Wall-mounted, with resistivity monitor.
BETTER WATER, LLC
EQDTD-WM-RM-2
In Commercial Distribution

  • DD0001 ()
EQDTD-WM-RM-2

  • Combination water purification system
Used to controle the console used in dentistry for implantology, dental surgery and endodontic work.
Bien-Air Dental SA
1601192-001
In Commercial Distribution

  • J00716011920011 ()
1601192-001

  • Foot-switch, electrical
  • Surgical power tool system control unit, line-powered
Used to control the console used in dentistry for implantology, dental surgery and endodontic work.
Bien-Air Dental SA
1600631-001
In Commercial Distribution

  • J00716006310011 ()
1600631-001

  • Foot-switch, electrical
  • Surgical power tool system control unit, line-powered
Used to control the console used in dentistry for implantology, dental surgery and endodontic work.
Bien-Air Dental SA
1600281-001
In Commercial Distribution

  • J00716002810011 ()
1600281-001

  • Foot-switch, electrical
Immunoassay for the detection of the following drug substance(s) in human urine: COC / OPI
LUMIQUICK DIAGNOSTICS, INC.
07RD7108-02
In Commercial Distribution

  • M90107RD7108020 ()

  • Length: 74 Millimeter
07RD7108-02

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: COC / THC
LUMIQUICK DIAGNOSTICS, INC.
07RD7108-01
In Commercial Distribution

  • M90107RD7108010 ()

  • Length: 74 Millimeter
07RD7108-01

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: BZD / OPI-2000
LUMIQUICK DIAGNOSTICS, INC.
07RD7061-04A
In Commercial Distribution

  • M90107RD706104A1 ()
  • M90107RD706104A0 ()

  • Length: 75 Millimeter
07RD7061-04A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
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