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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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X-MARK - B8870010080

1.15mm x 2cm X-MARK Preloaded in 17 g Needle
Izi Medical Products, LLC
001008
In Commercial Distribution

  • B8870010080 ()
001008

  • Radiological image marker, implantable

X-Mark Ultra - B88710780

0.85mm x 2cm X-MARK ULTRA Preloaded in 18g Needle
Izi Medical Products, LLC
1078
In Commercial Distribution

  • B88710780 ()
1078

  • Radiological image marker, implantable

X-Mark Ultra - B88710680

1.15mm x 2cm X-MARK ULTRA Preloaded in 17g needle
Izi Medical Products, LLC
1068
In Commercial Distribution

  • B88710680 ()
1068

  • Radiological image marker, implantable

Hayden Medical - 00840319750490

Martin Pelvimeter 13-1/2" (34cm), graduated in cm's & inches
Hayden Medical, Inc.
360-525
In Commercial Distribution

  • 00840319750490 ()
360-525

  • Obstetrical forceps, reusable

SporView™ VH2O2 Self-Contained Hydrogen Peroxide Biological Indicator - 10732224721504

Self-Contained BI for use in monitoring VH2O2 sterilization processes
CROSSTEX INTERNATIONAL, INC.
VH50
Not in Commercial Distribution

  • 50732224721502 ()
  • 10732224721504 ()
  • 00732224721507 ()


  • Biological sterilization indicator

EO Gas Chemical Indicator Strips - 10732224710317

8 in ( 203 mm x 16 mm), Type 4
SPS Medical Supply Corp.
GIL-250
In Commercial Distribution

  • 50732224710315 ()
  • 10732224710317 ()
  • 00732224710310 ()
GIL-250

  • Chemical/physical sterilization process indicator

Luvena - 00899655002152

Luvena Enhanced Personal Lubricant - 1.3oz bottle in unit carton
LACLEDE, INC.
Personal Lubricant
In Commercial Distribution

  • 00899655002152 ()


  • Sexual lubricant

CHS - 03596010083302

GUIDE WIRE 1/8 X 9 IN TROCAR POINT
Smith & Nephew, Inc.
128198
In Commercial Distribution

  • 23596010083306 ()
  • 03596010083302 ()
128198

  • Orthopaedic trocar blade, reusable

ColonPRO™ 4.0 - 08055060110345

Software to be used in GI Genius™ systems.
LINKVERSE SRL
4.0.1
In Commercial Distribution

  • 78055060110344 ()
  • 08055060110345 ()
CPRO401-US

  • Endoscopic video image interpretive software

PASS MED - 03613720225997

ROD FOR IN SITU BENDING Ø 6mm x 500mm
MEDICREA INTERNATIONAL
B01176500
Not in Commercial Distribution

  • 03613720225997 ()


  • Bone-screw internal spinal fixation system, non-sterile
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