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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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The AquaBplus Water Purification Systems are reverse osmosis units intended for use with hemodialysis systems to remove organic and inorganic substances and microbial contaminants from the water used for treating hemodialysis patients or related therapies. These devices are intended to be a component in a complete water purification system, and are not complete water treatment systems. Each reverse osmosis unit must be preceded by pre-treatment devices, and may need to be followed by post-treatment devices as well, to meet current AAMI/ANSI/ISO and Federal (U.S.) standards.
VIVONIC GmbH
2500
In Commercial Distribution

  • 04251285200227 ()


  • Reverse-osmosis water purification system
The AquaBplus Water Purification Systems are reverse osmosis units intended for use with hemodialysis systems to remove organic and inorganic substances and microbial contaminants from the water used for treating hemodialysis patients or related therapies. These devices are intended to be a component in a complete water purification system, and are not complete water treatment systems. Each reverse osmosis unit must be preceded by pre-treatment devices, and may need to be followed by post-treatment devices as well, to meet current AAMI/ANSI/ISO and Federal (U.S.) standards.
VIVONIC GmbH
2000
In Commercial Distribution

  • 04251285200210 ()


  • Reverse-osmosis water purification system
The AquaBplus Water Purification Systems are reverse osmosis units intended for use with hemodialysis systems to remove organic and inorganic substances and microbial contaminants from the water used for treating hemodialysis patients or related therapies. These devices are intended to be a component in a complete water purification system, and are not complete water treatment systems. Each reverse osmosis unit must be preceded by pre-treatment devices, and may need to be followed by post-treatment devices as well, to meet current AAMI/ANSI/ISO and Federal (U.S.) standards.
VIVONIC GmbH
1500
In Commercial Distribution

  • 04251285200203 ()


  • Reverse-osmosis water purification system
The AquaBplus Water Purification Systems are reverse osmosis units intended for use with hemodialysis systems to remove organic and inorganic substances and microbial contaminants from the water used for treating hemodialysis patients or related therapies. These devices are intended to be a component in a complete water purification system, and are not complete water treatment systems. Each reverse osmosis unit must be preceded by pre-treatment devices, and may need to be followed by post-treatment devices as well, to meet current AAMI/ANSI/ISO and Federal (U.S.) standards.
VIVONIC GmbH
1000
In Commercial Distribution

  • 04251285200197 ()


  • Reverse-osmosis water purification system
The AquaBplus Water Purification Systems are reverse osmosis units intended for use with hemodialysis systems to remove organic and inorganic substances and microbial contaminants from the water used for treating hemodialysis patients or related therapies. These devices are intended to be a component in a complete water purification system, and are not complete water treatment systems. Each reverse osmosis unit must be preceded by pre-treatment devices, and may need to be followed by post-treatment devices as well, to meet current AAMI/ANSI/ISO and Federal (U.S.) standards.
VIVONIC GmbH
500
In Commercial Distribution

  • 04251285200180 ()


  • Reverse-osmosis water purification system
Implantable Cardioverter Defibrillator DR
BOSTON SCIENTIFIC CORPORATION
D533
In Commercial Distribution

  • 00802526588310 ()


  • Dual-chamber implantable defibrillator
Implantable Cardioverter Defibrillator VR
BOSTON SCIENTIFIC CORPORATION
D532
In Commercial Distribution

  • 00802526588280 ()


  • Single-chamber implantable defibrillator
AIX1000 Rapid Plasma Reagin (RPR) Analyzer (refurbished)
Gold Standard Diagnostics Corporation
00400R
In Commercial Distribution

  • B35000400R0 ()
00400R

  • Agglutination assay digital imaging reader/analyser IVD
  • Treponema pallidum reagin antibody IVD, kit, agglutination
AIX1000 Rapid Plasma Reagin (RPR) Analyzer
Gold Standard Diagnostics Corporation
00400
In Commercial Distribution

  • B350004000 ()


  • Treponema pallidum reagin antibody IVD, kit, agglutination
  • Agglutination assay digital imaging reader/analyser IVD
FOOTSWITCH 2 PEDALS L 5M FOR HF SURGERY GENERATOR 400KHZ, with fixed connection cable, reusable
Richard Wolf GmbH
2260021
In Commercial Distribution

  • 04055207063330 ()

  • Length: 5 Meter
2260021

  • Foot-switch, electrical
Ergonomic carbon handle w. ratchet, ratchet with on / off system, HF connector male 45° angled
ELMED INCORPORATED
R52555-40-10
In Commercial Distribution

  • 00198506073892 ()
R52555-40-10

  • Laparoscopic surgical procedure kit, non-medicated, reusable
Biopsy-Forceps, Ø5mm, WL 330mm, double action jaw, shaft insulated, metal handle insulated, HF- connection, detachable
Hermann Medizintechnik GmbH
H40-533-641
In Commercial Distribution

  • 04059453003539 ()


  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
10mm Bariatric Length Spoon Forceps, Comfort Grip, Carbon Fiber, On/Off Ratchet, Rotating, HF Post
Surgical Direct, Inc.
SD16608-14
In Commercial Distribution

  • B382SD16608140 ()

  • Length: 36 Centimeter
  • Outer Diameter: 10 Millimeter
SD16608-14

  • Endoscope sheath, reusable
5mm 33cm Maryland Dissector,18mm Curved Jaw, Rotatable, with Insulated, Non Locking HF Handle, Flus
Surgical Direct, Inc.
SD881322L
In Commercial Distribution

  • B382SD881322L0 ()
SD881322L

  • Laparoscopic tissue manipulation forceps/working-channel
5mm 33cm Maryland Dissector, Standard 20mm Curved Jaw, Rotatable, with Insulated, Non Locking HF Han
Surgical Direct, Inc.
SD881322b
In Commercial Distribution

  • B382SD881322B0 ()
SD881322b

  • Laparoscopic tissue manipulation forceps/working-channel
5mm 33cm Maryland Dissector, Standard 18mm Curved Jaw, Rotatable, with Insulated, Non Locking HF Han
Surgical Direct, Inc.
SD881322
In Commercial Distribution

  • B382SD8813220 ()
SD881322

  • Laparoscopic tissue manipulation forceps/working-channel
5mm DeBakey Curved Tissue Forceps, Non- Locking, Insulated, Stainless Steel Handle, Rotating with HF Port
Surgical Direct, Inc.
SD88922
In Commercial Distribution

  • B382SD889220 ()
SD88922

  • Laparoscopic tissue manipulation forceps/working-channel
Tita Jet Light II PUR Kit HF with 8F x 750 mm Attachable Polyurethane Catheter
PFM MEDICAL INCORPORATED
616.368.2080-A
In Commercial Distribution

  • 07640110981757 ()
  • 07640110987988 ()


  • Vascular port/catheter
Jet Port Plus II PUR Kit HF with 8F x 750 mm Attachable Polyurethane Catheter
PFM MEDICAL INCORPORATED
616.367.2080-A
In Commercial Distribution

  • 07640110981702 ()
  • 07640110987940 ()


  • Vascular port/catheter
T-Port PUR Kit HF with 8F x 750 mm Attachable Polyurethane Catheter and Silicone Plugs
PFM MEDICAL INCORPORATED
616.365.2081-A
In Commercial Distribution

  • 07640110981603 ()
  • 07640110987537 ()


  • Vascular port/catheter
Biopsy Forceps, Oval Fenestrated Jaws, Monopolar HF Port, Single Action, Non-Ratchet Handle with Rotation Lock
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
35-402
Not in Commercial Distribution

  • H834354021 ()
  • 10381780152217 ()


  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
Biopsy Punch, Serrated Lower Jaw, Monopolar HF Port, Single Action, Non-Ratchet Handle with Rotation Lock
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
35-401
Not in Commercial Distribution

  • H834354011 ()
  • 10381780152200 ()


  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
Bullet Nose Dissecting Forceps, Dual Action Jaws, Monopolar HF Port, Non-Ratchet Handle with Rotation Lock
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
35-203
Not in Commercial Distribution

  • H834352031 ()
  • 10381780152194 ()


  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
Tapered MARYLAND Dissector, Curved Double Action Jaws, Monopolar HF Port, Non-Ratchet Handle with Rotation Lock
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
35-200
Not in Commercial Distribution

  • H834352001 ()
  • 10381780152187 ()


  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
Supercut METZENBAUM Scissors, Curved Dual Action Jaws, Monopolar HF Port, Non-Ratchet Handle with Rotation Lock
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
35-300
Not in Commercial Distribution

  • H834353001 ()
  • 10381780152828 ()


  • Rigid endoscopic scissors, reusable
PowerPICC HF Catheter with Sherlock Tip Location System (TLS) Stylet 5F Maximal Barrier Tray (Triple-Lumen)
Bard Access Systems, Inc.
9385108QD
In Commercial Distribution

  • 10801741035804 ()
  • 00801741035807 ()

  • Catheter Gauge: 5 French
  • Length: 55 Centimeter
9385108QD

  • Peripherally-inserted central venous catheter
PowerPICC HF Catheter with Sherlock 3CG Tip Positioning System (TPS) Stylet 5F Maximal Barrier Tray
Bard Access Systems, Inc.
1385108QD
In Commercial Distribution

  • 10801741034654 ()
  • 00801741034657 ()

  • Catheter Gauge: 5 French
  • Length: 55 Centimeter
1385108QD

  • Peripherally-inserted central venous catheter
PowerPICC HF Catheter with Sherlock 3CG Tip Positioning System (TPS) Stylet Full Tray (5F) (Triple-Lumen)
Bard Access Systems, Inc.
1385108Q
In Commercial Distribution

  • 10801741034647 ()
  • 00801741034640 ()

  • Length: 55 Centimeter
  • Catheter Gauge: 5 French
1385108Q

  • Peripherally-inserted central venous catheter
AIR-FLOW® handy 3.0 PERIO / PLUS Premium Adapter KaVo
E.M.S. Electro Medical Systems S.A.
FT-225#HF/A/007
In Commercial Distribution

  • 07613353202262 ()


  • Dental abrasive air jet system handpiece
MIDDLE EAR ANALYZER. Flute HF is a middle ear analyzer, capable of performing: tympanometry and acoustic reflex tests in sequence and automatically, ETF (Eustachian Tube Function) test for both intact and perforated eardrums, and tympanometry at 1000 Hz. Flute HF has, in addition, an integrated thermal printer.
INVENTIS SRL
FLUTE HF WITH PRINTER
In Commercial Distribution

  • 08054187380457 ()
10410

  • Impedance audiometer
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