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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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No Description
edelweiss dentistry products gmbh
13223
In Commercial Distribution

  • 09120046321639 ()


  • Dental veneer, professional
  • Dental composite resin
No Description
edelweiss dentistry products gmbh
13222
In Commercial Distribution

  • 09120046321622 ()


  • Dental composite resin
  • Dental veneer, professional
No Description
edelweiss dentistry products gmbh
13221
In Commercial Distribution

  • 09120046321615 ()


  • Dental veneer, professional
  • Dental composite resin
ISQ Measurement Peg
Osstell AB
Osstell SmartPeg Type 27
In Commercial Distribution

  • 09010522000250 ()
  • 09010522001394 ()
100431

  • Dental implant stability resonance frequency analysis peg
No Description
CareDx AB
101.521-04u
In Commercial Distribution

  • 07340035504641 ()


  • HLA class I antigen tissue typing IVD, kit, multiplex
No Description
CareDx AB
101.521-24u
In Commercial Distribution

  • 07340035504627 ()


  • HLA class I antigen tissue typing IVD, kit, multiplex
No Description
CareDx AB
101.532-48u
In Commercial Distribution

  • 07340035504580 ()


  • HLA class I antigen tissue typing IVD, kit, multiplex
No Description
CareDx AB
101.911-96u
In Commercial Distribution

  • 07340035504566 ()


  • HLA class I antigen tissue typing IVD, kit, multiplex
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
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
No Description
Berman Instruments LLC
BB279
Not in Commercial Distribution

  • 00810060722053 ()


  • Dental restoration carver, resin
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
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
Absorbent Paper Points, None Color 02 Taper 90/140, 180 Points, P 61
Meta Biomed Co., Ltd.
2911
In Commercial Distribution

  • 08806387829119 ()


  • Endodontic paper point
Absorbent Paper Points, None Color 02 Taper 90/140, 100 Points, P 61
Meta Biomed Co., Ltd.
2598
In Commercial Distribution

  • 08806387825982 ()


  • Endodontic paper point
"An absorbent paper points is an endodontic paper point that is used during the endodontic therapy to dry, or remove any foreign materials from the root canal of a tooth."
DiaDent Group International
VETERINARY POINTS(60mm B) ASST 90/110
In Commercial Distribution

  • 08806383516020 ()
218-295

  • Endodontic paper point
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
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
Performance Plus - Drift - Black Part Number: BL-92035 Material: Silicone
Blush Novelties
Performance Plus - Drift - Black
In Commercial Distribution

  • 00850002870664 ()
BL-92035

  • Penile ring
Performance Plus - Traction - Black Part Number: BL-92025 Material: Silicone
Blush Novelties
Performance Plus - Traction - Black
In Commercial Distribution

  • 00850002870657 ()
BL-92025

  • Penile ring
Performance Plus - Pursuit - Red Part Number: BL-92008 Material: Silicone
Blush Novelties
Performance Plus - Pursuit - Red
In Commercial Distribution

  • 00850002870640 ()
BL-92008

  • Penile ring
Performance Plus - Accelerate - Black Part Number: BL-92015 Material: Silicone
Blush Novelties
Performance Plus - Accelerate - Black
In Commercial Distribution

  • 00850002870633 ()
BL-92015

  • Penile ring
Performance Plus - Throttle - Black Part Number: BL-92005 Material: Silicone
Blush Novelties
Performance Plus - Throttle - Black
In Commercial Distribution

  • 00850002870619 ()
BL-92005

  • Penile ring
POWER CROWN REMOVER SET WITH CASSETTE- Patent Number D734,852
Power Dental U.S.A. Inc.
9023-IMCRC
In Commercial Distribution

  • D9439023IMCRC0 ()
9023-IMCRC

  • Device sterilization/disinfection container, reusable
  • Instrument tray, reusable
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
Fluid Dispensing Syringe Atrion Part Number 96423: 20mL, 120psi
ATRION MEDICAL PRODUCTS, INC.
QL20120
In Commercial Distribution

  • 10856877002572 ()
  • 00856877002575 ()
DP5050

  • Angiographic syringe
Valeo TL/PL Disc Prep, System Catalog Number Tag
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555910000024 ()
91.000.0024

  • Instrument tray, reusable
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
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 Mylar Blanket / Elite First Aid Part Number: 700
MEDSOURCE INTERNATIONAL LLC
ELITE-B100
In Commercial Distribution

  • 00816703023235 ()
  • 00816703023228 ()
Not Applicable

  • Rescue blanket, reusable
CPR Face Shield / Elite First Aid Part Number: 605
MEDSOURCE INTERNATIONAL LLC
ELITE-21105
In Commercial Distribution

  • 00816703023129 ()
  • 00816703023112 ()
Not Applicable

  • Cardiopulmonary resuscitation mouthpiece/cover
Self-Adherent Wrap-3x5yd,Black / Elite First Aid Part Number: 506
MEDSOURCE INTERNATIONAL LLC
ELITE-17113
In Commercial Distribution

  • 00840155407589 ()
  • 00816703023082 ()
Not Applicable

  • Non-adhesive device retention bandage
Self-Adherent Wrap - 4x5yds / Elite First Aid Part Number: 507
MEDSOURCE INTERNATIONAL LLC
ELITE-17104
In Commercial Distribution

  • 00816703023075 ()
  • 00816703023068 ()
Not Applicable

  • Non-adhesive device retention bandage
Triangular Bandage, nonwoven / Elite First Aid Part Number: 549
MEDSOURCE INTERNATIONAL LLC
ELITE-11050
In Commercial Distribution

  • 00840155407572 ()
  • 00816703023037 ()
Not Applicable

  • Collar and cuff arm sling material
Custom fit for DEXcam3 Re-Order Dexis Part Number 0.822.5921
TIDI PRODUCTS, LLC
21003
In Commercial Distribution

  • 20618125131048 ()
  • 10618125131041 ()
  • 00618125131044 ()
0.822.6921

  • Medical equipment/instrument drape, single-use
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