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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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STEIN PIN SNGL 3 SH 9/64" 3.5MM (6PK) 9"
TELEFLEX INCORPORATED
IPN015863
In Commercial Distribution

  • 24026704293524 ()
  • 04026704293520 ()

  • Width: 3.5 Millimeter
  • Length: 9 Inch
KM71492

  • Orthopaedic bone pin, non-bioabsorbable
STEINMANN PIN DIAMOND POINT BOTH ENDS 9/64 X 9
Smith & Nephew, Inc.
128121
In Commercial Distribution

  • 23596010083023 ()
  • 03596010083029 ()
128121

  • Orthopaedic bone pin, non-bioabsorbable
STEINMANN PIN DIAMOND POINT ROUND END 9/64 X 9
Smith & Nephew, Inc.
128120
In Commercial Distribution

  • 23596010083016 ()
  • 03596010083012 ()
128120

  • Orthopaedic bone pin, non-bioabsorbable
STEINMANN PIN DIAMOND POINT CHUCK END 9/64 X 9
Smith & Nephew, Inc.
128118
In Commercial Distribution

  • 23596010082996 ()
  • 03596010082992 ()
128118

  • Orthopaedic bone pin, non-bioabsorbable
STEINMANN PIN TROCAR POINT CHUCK END 9/64 X 9
Smith & Nephew, Inc.
128117
In Commercial Distribution

  • 23596010082989 ()
  • 03596010082985 ()
128117

  • Orthopaedic bone pin, non-bioabsorbable
STEINMANN PIN Trocar POINT BOTH ENDS 9/64 X 9
Smith & Nephew, Inc.
128116
In Commercial Distribution

  • 23596010082972 ()
  • 03596010082978 ()
128116

  • Orthopaedic bone pin, non-bioabsorbable
The G-EYE® System comprises the G-EYE® Colonoscope and the NaviAid™ SPARKC (also "SPARKC") air control system which controls inflation and deflation of the G-EYE® balloon. The G-EYE® balloon is inflated using ambient air and controlled by the SPARKC via a foot pedal or a remote panel.
SMART MEDICAL SYSTEMS LTD
SPARKC
In Commercial Distribution

  • 07290018671504 ()
40-016

  • Catheter/overtube balloon inflator, reusable
Sterile-Eo
Dynarex Corporation
36271
In Commercial Distribution

  • 00840117315273 ()
  • 00840117315259 ()


  • Nasopharyngeal airway, single-use
Provox Laryngectomy Kits provide all-in-one packaging for immediate post-operative 24/7 pulmonary rehabilitation and the option for ready-to-use surgical placement. The kits feature Provox Heat and Moisture Exchangers (HMEs) – approved for 24-hour use. These products are packed in a box and contain marketing materials and a mix of the following final products (configuration dependent): Provox Life LaryTube, Provox Life Home HME, Provox Life Night HME, Freevent Neckband two-piece L, Provox TubeBrush, Provox Life Shower, Provox SolaTone Plus, TruTone Plus
Atos Medical AB
6131
In Commercial Distribution

  • 07331791015380 ()
6131

  • Tracheostoma protective filter
  • Tracheostomy tube, non-reinforced, non-customized, reusable
  • Tracheostomy tube neck holder, single-use
  • Airway device cleaning utensil, noninvasive, reusable
  • Tracheostoma shower shield
Provox Laryngectomy Kits provide all-in-one packaging for immediate post-operative 24/7 pulmonary rehabilitation and the option for ready-to-use surgical placement. The kits feature Provox Heat and Moisture Exchangers (HMEs) – approved for 24-hour use. These products are packed in a box and contain marketing materials and a mix of the following final products (configuration dependent): Provox Life LaryTube, Provox Life Home HME, Provox Life Night HME, Freevent Neckband two-piece L, Provox TubeBrush, Provox Life Shower, Provox SolaTone Plus, TruTone Plus
Atos Medical AB
6139
In Commercial Distribution

  • 07331791015465 ()
6139

  • Tracheostoma protective filter
  • Tracheostomy tube, non-reinforced, non-customized, reusable
  • Tracheostomy tube neck holder, single-use
  • Airway device cleaning utensil, noninvasive, reusable
  • Tracheostoma shower shield
Provox Laryngectomy Kits provide all-in-one packaging for immediate post-operative 24/7 pulmonary rehabilitation and the option for ready-to-use surgical placement. The kits feature Provox Heat and Moisture Exchangers (HMEs) – approved for 24-hour use. These products are packed in a box and contain marketing materials and a mix of the following final products (configuration dependent): Provox Life LaryTube, Provox Life Home HME, Provox Life Night HME, Freevent Neckband two-piece L, Provox TubeBrush, Provox Life Shower, Provox SolaTone Plus, TruTone Plus
Atos Medical AB
6135
In Commercial Distribution

  • 07331791015427 ()
6135

  • Tracheostoma protective filter
  • Tracheostomy tube, non-reinforced, non-customized, reusable
  • Tracheostomy tube neck holder, single-use
  • Airway device cleaning utensil, noninvasive, reusable
  • Tracheostoma shower shield
Mediastinal Drain, High Capacity, Silicone, Eyes On Top & Bottom
AXIOM MEDICAL, INCORPORATED
111191
In Commercial Distribution

  • M6651111913 ()
  • M6651111911 ()
  • M6651111910 ()

  • 9 mm


  • Mediastinal drainage catheter, non-antimicrobial
Mediastinal Drain, Silicone, Eyes On Top & Bottom, With ClotStop®
AXIOM MEDICAL, INCORPORATED
111099AT
In Commercial Distribution

  • M665111099AT3 ()
  • M665111099AT1 ()
  • M665111099AT0 ()

  • 9 mm


  • Mediastinal drainage catheter, non-antimicrobial
Mediastinal Drain, Silicone, Eyes On Top, With ClotStop®
AXIOM MEDICAL, INCORPORATED
111096AT
In Commercial Distribution

  • M665111096AT3 ()
  • M665111096AT1 ()
  • M665111096AT0 ()

  • 9 mm


  • Mediastinal drainage catheter, non-antimicrobial
Mediastinal Drain, Silicone, Eyes On Sides
AXIOM MEDICAL, INCORPORATED
111095
In Commercial Distribution

  • M6651110953 ()
  • M6651110951 ()
  • M6651110950 ()

  • 9 mm


  • Mediastinal drainage catheter, non-antimicrobial
Mediastinal Drain, Silicone, Eyes On Top & Bottom
AXIOM MEDICAL, INCORPORATED
111099
In Commercial Distribution

  • M6651110993 ()
  • M6651110991 ()
  • M6651110990 ()

  • 9 mm


  • Mediastinal drainage catheter, non-antimicrobial
Mediastinal Drain, Silicone, Eyes On Top
AXIOM MEDICAL, INCORPORATED
111096
In Commercial Distribution

  • M6651110963 ()
  • M6651110961 ()
  • M6651110960 ()

  • 9 mm


  • Mediastinal drainage catheter, non-antimicrobial
Mediastinal Drain, Silicone, Eyes On Sides, With ClotStop®
AXIOM MEDICAL, INCORPORATED
111095AT
In Commercial Distribution

  • M665111095AT3 ()
  • M665111095AT1 ()
  • M665111095AT0 ()

  • 9 mm


  • Mediastinal drainage catheter, non-antimicrobial
No Description
Zimmer, Inc.
SSI005578
In Commercial Distribution

  • 00889024584082 ()

  • SZ 9
SSI005578

  • Orthopaedic prosthesis implantation positioning instrument, reusable
No Description
Zimmer, Inc.
SSI005432
In Commercial Distribution

  • 00889024583504 ()

  • Size 9
SSI005432

  • Orthopaedic prosthesis implantation positioning instrument, reusable
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