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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 Surgical - 00887482001066

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

NA - 10705034118567

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

NA - 10705034118550

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

Resp-O2 Nasopharyngeal Airway Kit, 9 NPA + 9 Packs of DynaLube - 00840117315273

Sterile-Eo
Dynarex Corporation
36271
In Commercial Distribution

  • 00840117315273 ()
  • 00840117315259 ()


  • Nasopharyngeal airway, single-use

Provox Life LP Kit 10 - LT 9/36, 9/55 - 07331791015465

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 Life LP Kit 6 - LT 9/36, 9/55 - 07331791015427

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 Life LP Kit 2 - LT 9/36, 9/55 - 07331791015380

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 - 03701354405417

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/VA - 03701354405400

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 - 03701354405219

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 FUJIFIL - 03701354405202

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 - 03701354405110

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 - 03701354405103

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 pu - 03701354405004

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 - 03701354404908

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 - 03701354404809

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 - 03701354404700

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 - 03701354404601

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 - 03701354404502

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 - 03701354404403

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 - 03701354404304

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 - 03701354404205

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 - 03701354404106

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) - 03701354404007

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 - 03701354403918

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 - 03701354403901

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 - 03701354403802

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 - 03701354403109

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, - 03701354403000

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 w - 03701354402904

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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