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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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Balanced Knee System - 00822409030293

LT Size 5 Narrow Femoral PS Nonporous
Ortho Development Corporation
161-1505A
In Commercial Distribution

  • 00822409030293 ()


  • Uncoated knee femur prosthesis, metallic

PK TECHNOLOGY - 00821925038073

PKS MOLly Forceps 5mm/33cm (5/Pk)
Gyrus ACMI, LLC
910005PK
In Commercial Distribution

  • 00821925009844 ()
  • 00821925038073 ()


  • Endoscopic electrosurgical handpiece/electrode, bipolar, single-use

PK TECHNOLOGY - 00821925041721

PKS MOLly Forceps 5mm/45cm (5/Pk)
Gyrus ACMI, LLC
910010PK
In Commercial Distribution

  • 00821925009905 ()
  • 00821925041721 ()


  • Endoscopic electrosurgical handpiece/electrode, bipolar, single-use

PK TECHNOLOGY - 00821925041691

PKS MOLly Forceps 5mm/45cm (5/Pk)
Gyrus ACMI, LLC
3345PK
In Commercial Distribution

  • 00821925009769 ()
  • 00821925041691 ()


  • Endoscopic electrosurgical handpiece/electrode, bipolar, single-use

InstaClear - 00821925040052

TUBESET, LENS CLEANER STANDARD InstaClear (5/PK)
Gyrus ACMI, LLC
LCTS100S
In Commercial Distribution

  • 00821925039889 ()
  • 00821925040052 ()


  • Endoscope lens cleaner, gas/fluid, single-use

PlasmaKinetic - 00821925039568

PLASMAKINETIC SYSTEM PK Plasma-V Instrument (5/PK)
Gyrus ACMI, LLC
714286
In Commercial Distribution

  • 00821925009226 ()
  • 00821925039568 ()


  • Endoscopic electrosurgical electrode, bipolar, single-use

Berkeley Vacurette - 00821925037601

VACURETTE "F" TIP 5 MM (10/PK)
Gyrus ACMI, LLC
21664
In Commercial Distribution

  • 00821925004597 ()
  • 00821925037601 ()


  • Surgical suction system collection container, single-use

Punches, NOBEL - 08056646504855

Guided Soft Tissue Punch RP 5/pkg
OMNIA SRL
32.Z2007.00
In Commercial Distribution

  • 08056646504848 ()
  • 08056646504855 ()


  • Dental soft-tissue coring punch, single-use

Punches, NOBEL - 08056646504831

Guided Soft Tissue Punch NP 5/pkg
OMNIA SRL
32.Z2006.00
In Commercial Distribution

  • 08056646504824 ()
  • 08056646504831 ()


  • Dental soft-tissue coring punch, single-use

Balanced Knee System - 00822409008261

RT Size 5 Wide Femoral CR Nonporous
Ortho Development Corporation
161-3508
In Commercial Distribution

  • 00822409008261 ()


  • Uncoated knee femur prosthesis, metallic
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