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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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Provox LaryTube is a holder for devices in the Provox HME System intended for vocal and pulmonary rehabilitation after total laryngectomy. For patients with a shrinking tracheostoma it is also used to maintain the tracheostoma for breathing. The Provox LaryTube is intended for single patient use. The Standard model is made for use with or without a voice prosthesis. The Standard model can be fenestrated so that air can go through the voice prosthesis for voice prosthesis users. The standard model can be attached with a Provox TubeHolder or Provox LaryClips.
Atos Medical AB
7601
In Commercial Distribution

  • 07331791002076 ()

  • Lumen/Inner Diameter: 9.5 Millimeter
  • Outer Diameter: 12.0 Millimeter
  • Length: 27 Millimeter
7601

  • Tracheostomy tube, non-reinforced, non-customized, reusable
Provox LaryTube is a holder for devices in the Provox HME System intended for vocal and pulmonary rehabilitation after total laryngectomy. For patients with a shrinking tracheostoma it is also used to maintain the tracheostoma for breathing. The Provox LaryTube is intended for single patient use. The Standard model is made for use with or without a voice prosthesis. The Standard model can be fenestrated so that air can go through the voice prosthesis for voice prosthesis users. The standard model can be attached with a Provox TubeHolder or Provox LaryClips.
Atos Medical AB
7613
In Commercial Distribution

  • 07331791002250 ()

  • Lumen/Inner Diameter: 13.5 Millimeter
  • Outer Diameter: 17.0 Millimeter
  • Length: 27 Millimeter
7613

  • Tracheostomy tube, non-reinforced, non-customized, reusable
Provox LaryTube is a holder for devices in the Provox HME System intended for vocal and pulmonary rehabilitation after total laryngectomy. For patients with a shrinking tracheostoma it is also used to maintain the tracheostoma for breathing. The Provox LaryTube is intended for single patient use. The Standard model is made for use with or without a voice prosthesis. The Standard model can be fenestrated so that air can go through the voice prosthesis for voice prosthesis users. The standard model can be attached with a Provox TubeHolder or Provox LaryClips.
Atos Medical AB
7609
In Commercial Distribution

  • 07331791002199 ()

  • Lumen/Inner Diameter: 12.0 Millimeter
  • Outer Diameter: 15.0 Millimeter
  • Length: 27 Millimeter
7609

  • Tracheostomy tube, non-reinforced, non-customized, reusable
Provox LaryTube is a holder for devices in the Provox HME System intended for vocal and pulmonary rehabilitation after total laryngectomy. For patients with a shrinking tracheostoma it is also used to maintain the tracheostoma for breathing. The Provox LaryTube is intended for single patient use. The Standard model is made for use with or without a voice prosthesis. The Standard model can be fenestrated so that air can go through the voice prosthesis for voice prosthesis users. The standard model can be attached with a Provox TubeHolder or Provox LaryClips.
Atos Medical AB
7605
In Commercial Distribution

  • 07331791002137 ()

  • Lumen/Inner Diameter: 10.5 Millimeter
  • Outer Diameter: 13.5 Millimeter
  • Length: 27 Millimeter
7605

  • Tracheostomy tube, non-reinforced, non-customized, reusable
No Description
Berman Instruments LLC
BB279
Not in Commercial Distribution

  • 00810060722053 ()


  • Dental restoration carver, resin
VersaPak Bracket, Retainer, Silicone, 0.27 in
SYMMETRY SURGICAL INC.
50-8584
In Commercial Distribution

  • 00887482154977 ()

  • Length: .27 Inch
  • Length: .27 Inch
50-8584

  • Device sterilization/disinfection container, reusable
SenSura Mio . 2-piece.
Coloplast A/S
18390
In Commercial Distribution

  • 05701780255103 ()
  • 05701780253758 ()
  • 05701780255875 ()

  • Base Plate Precut Start Hole Size - mm 10
  • Lumen/Inner Diameter: 90 Millimeter
  • Base Plate Max Cut Size - mm 88
  • Base Plate Max Cut Size - in 3 7/16
  • Base Plate Type Flat
  • Base Plate Precut Start Hole Size - in 3/8
  • Coupling Size Diameter - in 3 9/16
18390

  • Intestinal ostomy base plate, flat
No Description
Coloplast A/S
10108
In Commercial Distribution

  • 05708932384889 ()
  • 05708932384872 ()
  • 05701780043229 ()

  • Base Plate Type Flat
  • Base Plate Precut Start Hole Size - in 3/8
  • Coupling Size Diameter - in 3 9/16
  • Base Plate Precut Start Hole Size - mm 10
  • Lumen/Inner Diameter: 90 Millimeter
  • Base Plate Max Cut Size - in 3 7/16
  • Base Plate Max Cut Size - mm 88
10108

  • Intestinal ostomy base plate, flat
Case/Carton of 425 boxes of 50 TEST STRIPS HEPRO.US MM1000 - the FDA number is 3012098689 - the operator number is 10049962
HEPRO.US INC.
Hepro.usTSC
In Commercial Distribution

  • 00850578007389 ()
  • 85057800738902 ()


  • Glucose monitoring system IVD, home-use
The patient cable is used to connect the HFVI Sensor (UDI number 03760232460245) to the acquisition box BA-HFVI-V1 (UDI number 03760232460184)
MDOLORIS MEDICAL SYSTEMS
1
In Commercial Distribution

  • 03760232460283 ()


  • Electrocardiographic lead set, reusable
Fluid Dispensing Syringe Atrion Part Number 96423: 20mL, 120psi
ATRION MEDICAL PRODUCTS, INC.
QL20120
In Commercial Distribution

  • 10856877002572 ()
  • 00856877002575 ()
DP5050

  • Angiographic syringe
PROBE,TEMP F/MARQUETTE N/S PART NUMBER 650405005
Edwards Lifesciences LLC
93524
In Commercial Distribution

  • 00690103197143 ()

  • Length: 78 Inch
93524

  • General-purpose patient temperature probe, reusable
Valeo TL/PL Disc Prep, System Catalog Number Tag
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555910000024 ()
91.000.0024

  • Instrument tray, reusable
Part Number 138200, Disposable Doppler Probe for Neurosurgery, Box
VASCULAR TECHNOLOGY, INCORPORATED
138200
In Commercial Distribution

  • 10817122020260 ()
  • 00817122020263 ()
138200

  • Invasive/noninvasive vascular ultrasound probe
Part Number 138660, Disposable Doppler Probe for Neurosurgery, Box
VASCULAR TECHNOLOGY, INCORPORATED
138660
In Commercial Distribution

  • 10817122020208 ()
  • 00817122020201 ()
138660

  • Invasive/noninvasive vascular ultrasound probe
ABD Pads, 5x9 / Elite First Aid Part Number: 5161
MEDSOURCE INTERNATIONAL LLC
ELITE-ABD5X9
In Commercial Distribution

  • 00840155407602 ()
  • 00840155407596 ()
  • 00840155407619 ()
Not Applicable

  • Woven gauze roll/sheet
Elite, Bleedstop Gauze / Elite First Aid Part Number: 550
MEDSOURCE INTERNATIONAL LLC
ELITE-RG002
In Commercial Distribution

  • 00840155407756 ()
  • 00840155407688 ()
Not Applicable

  • Woven gauze roll/sheet
SPOTLIGHT ACCESS SYSTEM MICRODISCECTOMY CASE Number 2, TRAY 3
DEPUY SPINE, LLC
292900565
In Commercial Distribution

  • 10705034225333 ()
292900565

  • Instrument tray, reusable
SPOTLIGHT ACCESS SYSTEM MICRODISCECTOMY CASE Number 2, TRAY 2
DEPUY SPINE, LLC
292900560
In Commercial Distribution

  • 10705034225326 ()
292900560

  • Instrument tray, reusable
SPOTLIGHT ACCESS SYSTEM MICRODISCECTOMY CASE Number 2, TRAY 1
DEPUY SPINE, LLC
292900555
In Commercial Distribution

  • 10705034225319 ()
292900555

  • Instrument tray, reusable
SPOTLIGHT ACCESS SYSTEM MICRODISCECTOMY CASE Number 1, TRAY 2
DEPUY SPINE, LLC
292900510
In Commercial Distribution

  • 10705034225296 ()
292900510

  • Instrument tray, reusable
SPOTLIGHT ACCESS SYSTEM MICRODISCECTOMY CASE Number 1, TRAY 1
DEPUY SPINE, LLC
292900505
In Commercial Distribution

  • 10705034225289 ()
292900505

  • Instrument tray, reusable
Rail Extender, RH, EU GE Part Number: 5405553 009
HILL-ROM, INC.
112003
In Commercial Distribution

  • 00615521015534 ()
GE5405553

  • Temporary cardiac pacing balloon catheter
Rail Extender, LH, EU GE Part Number: 5405552 009
HILL-ROM, INC.
112003
In Commercial Distribution

  • 00615521015527 ()
GE5405552

  • Temporary cardiac pacing balloon catheter
Rail Extender, RH, US GE Part Number: 5404080 009
HILL-ROM, INC.
112003
In Commercial Distribution

  • 00615521015503 ()
GE5404080

  • Temporary cardiac pacing balloon catheter
S18061MA: Flexible Anesthesia Screen GE Part Number: 5402061 005
HILL-ROM, INC.
112002
In Commercial Distribution

  • 00615521015466 ()
GE5402061

  • Anaesthesia screen
Rail Extender, LH, US GE Part Number: 5402059 008
HILL-ROM, INC.
112003
In Commercial Distribution

  • 00615521015442 ()
GE5402059

  • Temporary cardiac pacing balloon catheter
Width Extender, Carbon Fiber GE Part Number: 5402056 007
HILL-ROM, INC.
112001
In Commercial Distribution

  • 00615521015428 ()
GE5402056

  • Operating table mattress, basic
Performance Plus - Launch - Black Part Number: BL-92045 Material: Silicone
Blush Novelties
Performance Plus - Launch - Black
In Commercial Distribution

  • 00850002870701 ()
BL-92045

  • Penile ring
Performance Plus - Flash - Multi Part Number: BL-92022 Material: Silicone
Blush Novelties
Performance Plus - Flash - Multi
In Commercial Distribution

  • 00850002870671 ()
BL-92022

  • Penile ring
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