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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IDENTITi PS POROUS Ti SPACER, 9 x 9 x 30 mm, 5°
ALPHATEC SPINE, INC.
120-09093005-S
In Commercial Distribution

  • 00190376193724 ()

  • Angle: 5 degree
  • Height: 9 Millimeter
  • Width: 9 Millimeter
  • Length: 30 Millimeter


  • Metallic spinal interbody fusion cage
IDENTITi PS POROUS Ti SPACER, 9 x 9 x 25 mm, 15°
ALPHATEC SPINE, INC.
120-09092515-S
In Commercial Distribution

  • 00190376193717 ()

  • Width: 9 Millimeter
  • Length: 25 Millimeter
  • Angle: 15 degree
  • Height: 9 Millimeter


  • Metallic spinal interbody fusion cage
IDENTITi PS POROUS Ti SPACER, 9 x 9 x 25 mm, 10°
ALPHATEC SPINE, INC.
120-09092510-S
In Commercial Distribution

  • 00190376193700 ()

  • Height: 9 Millimeter
  • Width: 9 Millimeter
  • Length: 25 Millimeter
  • Angle: 10 degree


  • Metallic spinal interbody fusion cage
IDENTITi PS POROUS Ti SPACER, 9 x 9 x 25 mm, 5°
ALPHATEC SPINE, INC.
120-09092505-S
In Commercial Distribution

  • 00190376193694 ()

  • Height: 9 Millimeter
  • Angle: 5 degree
  • Width: 9 Millimeter
  • Length: 25 Millimeter


  • Metallic spinal interbody fusion cage
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
NIST medical air probe 4 bar for MD-airmed CH with PU tube (diam. 8mm, length 1m)
PLASMABIOTICS
NIST-CH
In Commercial Distribution

  • 03701354407909 ()

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


  • Endoscope clean-storage system
Analogue manometer
PLASMABIOTICS
AMano
In Commercial Distribution

  • 03701354407206 ()

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


  • Endoscope clean-storage system
Gas flowrate meter
PLASMABIOTICS
GFRM-BH
In Commercial Distribution

  • 03701354407107 ()

  • Length: 25 Centimeter
  • Width: 20 Centimeter
  • Height: 20 Centimeter


  • Endoscope clean-storage system
Push-in connectors for PU tubes
PLASMABIOTICS
RR-DY68
In Commercial Distribution

  • 03701354407008 ()

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


  • Endoscope clean-storage system
Metallic push-in connectors for MD-airmed CH
PLASMABIOTICS
RR-CH
In Commercial Distribution

  • 03701354406902 ()

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


  • Endoscope clean-storage system
Polyurethane tube, int. diam. 5 mm, ext. diam. 8 mm, length 30 m
PLASMABIOTICS
TPU8-PT
In Commercial Distribution

  • 03701354406803 ()

  • Length: 40 Centimeter
  • Width: 27 Centimeter
  • Height: 7 Centimeter


  • Endoscope clean-storage system
Polyurethane tube, int. diam. 4 mm, ext. diam. 6 mm, length 30 m
PLASMABIOTICS
TPU6-PT
In Commercial Distribution

  • 03701354406704 ()

  • Length: 40 Centimeter
  • Width: 27 Centimeter
  • Height: 5 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 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
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
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
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
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
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
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
Autoclavable version of OP B-Bp
PLASMABIOTICS
OP B-Bp/A
In Commercial Distribution

  • 03701354401914 ()

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


  • Endoscope clean-storage system
Autoclavable version of OO P EB
PLASMABIOTICS
OO P EB/A
In Commercial Distribution

  • 03701354401815 ()

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


  • Endoscope clean-storage system
Silicone connection set for fiber- and video-bronchoscopes OLYMPUS
PLASMABIOTICS
OO P
In Commercial Distribution

  • 03701354401709 ()

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


  • Endoscope clean-storage system
Silicone connection set for ultrasound endoscopes OLYMPUS UC/UCT series
PLASMABIOTICS
OW E UCT
In Commercial Distribution

  • 03701354401600 ()

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


  • Endoscope clean-storage system
Silicone connection set for ultrasound endoscopes OLYMPUS UE/UM series
PLASMABIOTICS
OW E
In Commercial Distribution

  • 03701354401501 ()

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


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

  • 03701354401310 ()

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


  • Endoscope clean-storage system
Silicone connection set for ultrasound endoscopes FUJIFILM EG-580UR/UT
PLASMABIOTICS
Fg5 E580
In Commercial Distribution

  • 03701354401204 ()

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


  • Endoscope clean-storage system
Silicone connection set for ultrasound endoscopes FUJIFILM EG-530UR/UT
PLASMABIOTICS
Fg5 E530
In Commercial Distribution

  • 03701354401105 ()

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


  • Endoscope clean-storage system
Autoclavable version of Fg5 B-Bp
PLASMABIOTICS
Fg5 B-Bp/A
In Commercial Distribution

  • 03701354400917 ()

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


  • Endoscope clean-storage system
NIST medical air probe 7 bar for MD-airmed CH with PU tube (diam. 8mm, length 1m)
PLASMABIOTICS
NIST-CH-MA4
In Commercial Distribution

  • 03701354407916 ()

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


  • Endoscope clean-storage system
1000 red labels “To disinfect”
PLASMABIOTICS
EBag-RED
In Commercial Distribution

  • 03701354407800 ()

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


  • Endoscope clean-storage system
Autoclavable version of PW90 2C-G-D
PLASMABIOTICS
PW90 2C-G-D/A
In Commercial Distribution

  • 03701354407718 ()

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


  • Endoscope clean-storage system
Silicone connection set for colonoscopes, gastroscopes and duodenoscopes PENTAX 90 and i10 series with double operating channel
PLASMABIOTICS
PW90 2C-G-D
In Commercial Distribution

  • 03701354407701 ()

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


  • Endoscope clean-storage system
Ozone test strips
PLASMABIOTICS
OZTS-MN
In Commercial Distribution

  • 03701354407305 ()

  • Length: 12 Centimeter
  • Width: 4 Centimeter
  • Height: 4 Centimeter


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

  • 03701354404908 ()

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