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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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Symmetry® Case, Gouge & Osteotome, Dimensions 9 x 9 x 1.75 in
SYMMETRY SURGICAL INC.
21-2500
In Commercial Distribution

  • 00887482001066 ()

  • Length: 9 Inch
  • Width: 9 Inch
  • Height: 1.75 Inch
21-2500

  • Instrument tray, reusable
SURGICAL TITANIUM MESH TRAPEZOID MESH 9 x (9 x 11) x 20mm
DEPUY SPINE, LLC
186309509
In Commercial Distribution

  • 10705034118567 ()
186309509

  • Metallic spinal interbody fusion cage
SURGICAL TITANIUM MESH TRAPEZOID MESH 9 x (7 x 9) x 20mm
DEPUY SPINE, LLC
186309507
In Commercial Distribution

  • 10705034118550 ()
186309507

  • Metallic spinal interbody fusion cage
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
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
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
Autoclavable version of Oly C
PLASMABIOTICS
Oly C/A
In Commercial Distribution

  • 03701354405417 ()

  • Length: 34 Centimeter
  • Width: 23 Centimeter
  • Height: 3 Centimeter


  • Endoscope clean-storage system
Silicone connection set for cystoscopes (and ureteroscopes) OLYMPUS CYF-4A/5A/VA2/VHA/240A, intubation video-endoscopes OLYMPUS MAF-DM2/GM2/TM2, and fibro- and videobronchoscopes STORZ
PLASMABIOTICS
Oly C
In Commercial Distribution

  • 03701354405400 ()

  • Length: 34 Centimeter
  • Width: 23 Centimeter
  • Height: 3 Centimeter


  • Endoscope clean-storage system
Autoclavable version of Fg5W 2C-G-D
PLASMABIOTICS
Fg5W 2C-G-D/A
In Commercial Distribution

  • 03701354405219 ()

  • Length: 34 Centimeter
  • Width: 23 Centimeter
  • Height: 3 Centimeter


  • Endoscope clean-storage system
Silicone connection set for colonoscopes, gastroscopes and duodenoscopes FUJIFILM G5 series with double operating channel
PLASMABIOTICS
Fg5W 2C-G-D
In Commercial Distribution

  • 03701354405202 ()

  • Length: 34 Centimeter
  • Width: 23 Centimeter
  • Height: 3 Centimeter


  • Endoscope clean-storage system
Autoclavable version of PP EEB-J10
PLASMABIOTICS
PP EEB-J10/A
In Commercial Distribution

  • 03701354405110 ()

  • Length: 34 Centimeter
  • Width: 23 Centimeter
  • Height: 3 Centimeter


  • Endoscope clean-storage system
Silicone connection set for ultrasound bronchoscopes PENTAX EB19-J10U
PLASMABIOTICS
PP EEB-J10
In Commercial Distribution

  • 03701354405103 ()

  • Length: 34 Centimeter
  • Width: 23 Centimeter
  • Height: 3 Centimeter


  • Endoscope clean-storage system
Endoscope surrogate (channel system) and its connection set for demonstration purposes
PLASMABIOTICS
SG-endo
In Commercial Distribution

  • 03701354405004 ()

  • Length: 40 Centimeter
  • Width: 40 Centimeter
  • Height: 3 Centimeter


  • Endoscope clean-storage system
Demo Flight case
PLASMABIOTICS
FCD-Typhoon
In Commercial Distribution

  • 03701354404908 ()

  • Length: 71 Centimeter
  • Width: 42 Centimeter
  • Height: 35 Centimeter


  • Endoscope clean-storage system
Stainless steel bar-code (to attach), 10 units
PLASMABIOTICS
CBar-IN
In Commercial Distribution

  • 03701354404809 ()

  • Length: 20 Centimeter
  • Width: 12 Centimeter
  • Height: 3 Centimeter


  • Endoscope clean-storage system
Coplex bar-code (to attach), 10 units
PLASMABIOTICS
CBar-CP
In Commercial Distribution

  • 03701354404700 ()

  • Length: 20 Centimeter
  • Width: 12 Centimeter
  • Height: 3 Centimeter


  • Endoscope clean-storage system
Self-adhesive bar-code, 10 units
PLASMABIOTICS
CBar-AC
In Commercial Distribution

  • 03701354404601 ()

  • Length: 20 Centimeter
  • Width: 12 Centimeter
  • Height: 3 Centimeter


  • Endoscope clean-storage system
Thermal transfer ribbon 74 m for TSC printer
PLASMABIOTICS
Fterm
In Commercial Distribution

  • 03701354404502 ()

  • Length: 4 Centimeter
  • Width: 4 Centimeter
  • Height: 11 Centimeter


  • Endoscope clean-storage system
Media roll with 1100 labels for TSC printer
PLASMABIOTICS
Eterm
In Commercial Distribution

  • 03701354404403 ()

  • Length: 12 Centimeter
  • Width: 12 Centimeter
  • Height: 11 Centimeter


  • Endoscope clean-storage system
Shutters 1000 units
PLASMABIOTICS
OBag
In Commercial Distribution

  • 03701354404304 ()

  • Length: 20 Centimeter
  • Width: 12 Centimeter
  • Height: 3 Centimeter


  • Endoscope clean-storage system
1000 double-layer labels, green and red
PLASMABIOTICS
EBag-DC
In Commercial Distribution

  • 03701354404205 ()

  • Length: 40 Centimeter
  • Width: 30 Centimeter
  • Height: 10 Centimeter


  • Endoscope clean-storage system
1000 pre-printed labels for manual traceability
PLASMABIOTICS
EBag
In Commercial Distribution

  • 03701354404106 ()

  • Length: 34 Centimeter
  • Width: 23 Centimeter
  • Height: 2 Centimeter


  • Endoscope clean-storage system
Storage connection set (for plasma injection)
PLASMABIOTICS
PBag-inj
In Commercial Distribution

  • 03701354404007 ()

  • Length: 34 Centimeter
  • Width: 23 Centimeter
  • Height: 3 Centimeter


  • Endoscope clean-storage system
XL PlasmaBAG, size: 70cm x 64cm, 250 units packaging
PLASMABIOTICS
PBagXL
In Commercial Distribution

  • 03701354403918 ()

  • Length: 67 Centimeter
  • Width: 56 Centimeter
  • Height: 13 Centimeter


  • Endoscope clean-storage system
XXL PlasmaBAG, size: 84cm x 60cm, 300 units packaging
PLASMABIOTICS
PBagXXL
In Commercial Distribution

  • 03701354403901 ()

  • Length: 67 Centimeter
  • Width: 56 Centimeter
  • Height: 13 Centimeter


  • Endoscope clean-storage system
Standard PlasmaBAG, size: 60cm x 50cm, 400 units packaging
PLASMABIOTICS
PBag
In Commercial Distribution

  • 03701354403802 ()

  • Length: 59 Centimeter
  • Width: 56 Centimeter
  • Height: 13 Centimeter


  • Endoscope clean-storage system
Silicone connection set for double-channel ureteroscope WOLF Cobra
PLASMABIOTICS
Wol U2c
In Commercial Distribution

  • 03701354403109 ()

  • Length: 34 Centimeter
  • Width: 23 Centimeter
  • Height: 3 Centimeter


  • Endoscope clean-storage system
Silicone connection set for cystoscopes and ureteroscopes WOLF, STORZ, OLYMPUS, PENTAX with two luer-lock channel entrances
PLASMABIOTICS
Wol U
In Commercial Distribution

  • 03701354403000 ()

  • Length: 34 Centimeter
  • Width: 23 Centimeter
  • Height: 3 Centimeter


  • Endoscope clean-storage system
Silicone connection set for cystoscopes and ureteroscopes WOLF, STORZ, OLYMPUS with one luer-lock channel entrance
PLASMABIOTICS
Wol C
In Commercial Distribution

  • 03701354402904 ()

  • Length: 34 Centimeter
  • Width: 23 Centimeter
  • Height: 3 Centimeter


  • Endoscope clean-storage system
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