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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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Micro-Introducer Kit with Side-Holes - 00841268105751

Micro-Introducer Kit with Side-Holes
GALT MEDICAL CORP.
KIT-033-24
Not in Commercial Distribution

  • 20841268105755 ()
  • 10841268105758 ()
  • 00841268105751 ()

  • Catheter Gauge: 4 French
KIT-033-24

  • Vascular catheter introduction set, nonimplantable

AuDX Device with touchscreen - 04260223143281

AuDX branded Sentiero
PATH medical GmbH
100098-AU
In Commercial Distribution

  • 04260223143281 ()


  • Evoked-potential audiometer

coflex-F Handle with ratchet - 04260148897689

No Description
Paradigm Spine GmbH
RAT20500
In Commercial Distribution

  • 04260148897689 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable

Simplex HV with Gentamicin - 04260056885761

Simplex® HV with Gentamicin is a fast-setting acrylic resin with addition of gentamicin sulfate for use in bone surgery. Mixing the two separate sterile components produces a ductile bone cement which, after hardening, fixes the implant and transfers stresses produced during movement evenly to the bone. Simplex® HV with Gentamicinn cement powder also contains insoluble zirconium dioxide as an X-ray contrast medium. Simplex® HV with Gentamicin does not emit a signal and does not pose a safety risk in a magnetic resonance environment.
OSARTIS GmbH
6195-1-001
In Commercial Distribution

  • 24260056885765 ()
  • 14260056885768 ()
  • 04260056885761 ()

  • Total Volume: 20 Milliliter
  • Weight: 40.8 Gram
6195-1-010

  • Orthopaedic cement, antimicrobial

Reusable Probes with Holes - 00607915117078

Reusable Probes with holes.
APPLIED MEDICAL RESOURCES CORPORATION
C6204
Not in Commercial Distribution

  • 00607915117078 ()

  • Length: 33 Centimeter
  • Outer Diameter: 10 Millimeter


  • Surgical irrigation/aspiration handpiece, reusable

Cannulas with Universal Seals - 00607915114954

Laparoscopic Trocar Sleeve
APPLIED MEDICAL RESOURCES CORPORATION
C0652
Not in Commercial Distribution

  • 10607915114951 ()
  • 00607915114954 ()

  • Length: 100 Millimeter
  • Lumen/Inner Diameter: 12 Millimeter


  • Laparoscopic access cannula, single-use

Cannulas with Universal Seals - 00607915114947

Laparoscopic Trocar Sleeve
APPLIED MEDICAL RESOURCES CORPORATION
C0651
Not in Commercial Distribution

  • 10607915114944 ()
  • 00607915114947 ()

  • Length: 100 Millimeter
  • Lumen/Inner Diameter: 11 Millimeter


  • Laparoscopic access cannula, single-use

Circulatory Circuit with RF32 - 00607567209978

BEQ-HMOD 70000-USA Adult Quadrox iD, BEQ-RF32 RotaFlow, Gas Filter
DATASCOPE CORP.
BEQ-TOP 53600
In Commercial Distribution

  • 00607567209978 ()
709000218

  • Cardiopulmonary bypass system blood tubing set

Adult ECC with RF32 - 00607567207141

Softshell venous reservoir 1900 BEQ-RF32 RotaFlow
DATASCOPE CORP.
BEQ-T 21308
Not in Commercial Distribution

  • 00607567207141 ()
701068376

  • Cardiopulmonary bypass system blood tubing set

ECC Pack with PQID - 00607567205574

BEQ HMOD 30000 Blood Transfer Bag Better Bladder Blood Microfilter System Cardiopegia Filter Gas Filter Pediatric Temp Probe
DATASCOPE CORP.
BEQ-TOP 24105
Not in Commercial Distribution

  • 00607567205574 ()
701064757

  • Cardiopulmonary bypass system blood tubing set
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