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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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SPACER 1-2212 US 12MM X-STOP
MEDTRONIC SOFAMOR DANEK, INC.
1-2212
In Commercial Distribution

  • 00643169132719 ()

  • Minor Diameter 12mm


  • Lumbar decompression interspinous spacer
SPACER 1-2214 US 14MM X-STOP
MEDTRONIC SOFAMOR DANEK, INC.
1-2214
In Commercial Distribution

  • 00643169132702 ()

  • Minor Diameter 14mm


  • Lumbar decompression interspinous spacer
PROG 37754 RESTORE SENSOR RECHARGE SYS
MEDTRONIC, INC.
37754
Not in Commercial Distribution

  • 00643169119215 ()


  • Noninvasive device battery charger
INSERTER 2-2001 MAINBODY X STOP INST US
MEDTRONIC SOFAMOR DANEK, INC.
2-2001
In Commercial Distribution

  • 00643169117761 ()


  • Orthopaedic inorganic implant inserter/extractor, reusable
INSERTER 2-2002 UNI WING X STOP INST US
MEDTRONIC SOFAMOR DANEK, INC.
2-2002
In Commercial Distribution

  • 00643169117754 ()


  • Orthopaedic inorganic implant inserter/extractor, reusable
Deflux metal needle
PALETTE LIFE SCIENCES, INC.
3.7 FR x 23 G (tip) x 350 mm
In Commercial Distribution

  • 00850004725023 ()

  • Length: 350 Millimeter
  • Needle Gauge: 23 Gauge
DX1201

  • Submucosal injection needle
Solesta injectable gel
PALETTE LIFE SCIENCES, INC.
Gel 1.0 mL Syringe
In Commercial Distribution

  • 00850004725016 ()

  • Total Volume: 1 Milliliter
011506

  • Anal tissue reconstructive material
Deflux injectable gel
PALETTE LIFE SCIENCES, INC.
Gel 1.0 mL Syringe
In Commercial Distribution

  • 00850004725009 ()

  • Total Volume: 1 Milliliter
011504

  • Urinary tract reconstructive material, microbe-derived
Bond Oracle HER2 IHC System is a semi quantitative immunohistochemical assay to determine HER2 oncoprotein status in breast cancer in breast tissue processed for histological evaluation.
LEICA BIOSYSTEMS NEWCASTLE LTD
TA9145
In Commercial Distribution

  • 05055331301291 ()
TA9145

  • Human epidermal growth factor receptor 2 (HER2) protein IVD, kit, enzyme immunohistochemistry
Reusable Filshie Clip Applicator for minilaparotomy
FEMCARE LIMITED
AVM-856
Not in Commercial Distribution

  • 05055515602169 ()
AVM-856

  • Fallopian tube clip/band
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