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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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The Scalar Wave Laser System is indicated for temporary relief of minor muscle and joint pain, arthritis and muscle spasm, relieving stiffness, promoting relaxation of muscle tissue, and to temporarily increase local blood circulation where heat is indicated.
STELLAR LASERS LLC
600120
In Commercial Distribution

  • B3926001200 ()


  • Musculoskeletal/physical therapy laser, home-use
The Scalar Wave Laser System is indicated for temporary relief of minor muscle and joint pain, arthritis and muscle spasm, relieving stiffness, promoting relaxation of muscle tissue, and to temporarily increase local blood circulation where heat is indicated.
STELLAR LASERS LLC
600110
In Commercial Distribution

  • B3926001100 ()


  • Musculoskeletal/physical therapy laser, home-use
The Scalar Wave Laser System is indicated for temporary relief of minor muscle and joint pain, arthritis and muscle spasm, relieving stiffness, promoting relaxation of muscle tissue, and to temporarily increase local blood circulation where heat is indicated.
STELLAR LASERS LLC
600100
In Commercial Distribution

  • B3926001000 ()


  • Musculoskeletal/physical therapy laser, home-use
ACE™ Brand Sports Tape 207465, 1-pack; 1.5" x 10 yds
3M COMPANY
207465
In Commercial Distribution

  • 50051131203667 ()
  • 00051131203662 ()
  • 00051131208162 ()
207465

  • Hypoallergenic skin adhesive tape
All Sports Athletic Tape Retail blister, red, Tape and Bandage, Adhesive
CRAMER PRODUCTS, INC.
762700
In Commercial Distribution

  • 80311960751632 ()
  • 20311960751630 ()
  • 00311960751636 ()

  • Width: 1.5 Inch
  • Length: 10 Yard


  • Dressing-fixation skin adhesive tape, non-silicone
Light weight (~2.5 Kg.) and portable therapeutic medical laser device (measuring ~258.65mm x 238.43m x 88.86mm) disc shaped, indicated for temporary relief of minor muscle and joint pain, stiffness, minor arthritis pain, muscle spasm, temporary increase in local blood circulation, and temporary relaxation of muscles by means of topical elevated tissue temperature from infrared spectral emissions. The noninvasive laser treatments (Continuous Wave - CW power 28W and Intense Super Pulse - ISP power 30W) are in the form of non-ionizing radiation in which the invisible light wave doses (810nm +/- 10nm, 915nm +/- 10nm, 980nm +/- 10nm) and visible light wave aiming beam (650nm +/- 20nm) are not cumulative and do not create changes in cellular DNA. The presence of a temperature gradient generates an increased local blood circulation through the tissue to reduce inflammation and pain and to enhance the rate of tissue repair. The laser energy increases circulation, drawing water, oxygen, and nutrients to the target area. The increase in circulation provides a healing environment that reduces inflammation, swelling, muscle spasm, stiffness, and pain. The increased circulation of blood speeds up the process of respiratory cellular activity by stimulating an increase in hemoglobin and nutrients at the target cell and a decrease in cellular carbon dioxide and lactic acid waste. The laser light therapy promotes the transport of nutrients across the cell membrane to aid in the natural repair mechanism of the target cells by stimulating an increase in production of Adenosine Triphosphate (ATP) energy in the cell. The increase in ATP energy and the decrease in waste enhances cellular function and tissue repair.
SUMMUS MEDICAL LASER, LLC
P4H
In Commercial Distribution

  • B679SLP4H0 ()
SLP4H

  • Musculoskeletal/physical therapy laser, professional
I5 Insert to process up to 30 kidney bowls (requires Universal rack I5-2LR).
SKYTRON LLC
I5-RIKB
In Commercial Distribution

  • 10841736100582 ()
I5-RIKB

  • Surgical instrument washer/disinfector (chemical/thermal)
Amalgam Well
HU-FRIEDY MFG. CO., LLC
WA
Not in Commercial Distribution

  • 10889950037529 ()
WA

  • Dental amalgam well
Well, Amalgam
HU-FRIEDY MFG. CO., LLC
U5600
Not in Commercial Distribution

  • 10889950124823 ()
U5600

  • Dental amalgam well
Amalgam Well
HU-FRIEDY MFG. CO., LLC
WELL
In Commercial Distribution

  • 10889950142438 ()


  • Dental amalgam well
Amalgam Well, Round Bottom
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
71-96
Not in Commercial Distribution

  • H83471960 ()
  • 10381780496755 ()
71-96

  • Dental amalgam well
Amalgam Well - Stainless Steel
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
700100-0000-001
Not in Commercial Distribution

  • H83470010000000010 ()
  • 10381780506942 ()
700100-0000-001

  • Dental amalgam well
AMALGAM WELL KNURLED DORLIN
DARBY DENTAL SUPPLY, LLC
9501100
In Commercial Distribution

  • 00889813028544 ()
9501100

  • Dental amalgam well
A small cup where mixed amalgam is put before being taken up by an amalgam carrier or an amalgam syringe. This is a reusable device.
OSUNG MND Co., Ltd.
PLGWL1
In Commercial Distribution

  • 08800075626325 ()


  • Dental amalgam well
Amalgam Well
HENRY SCHEIN, INC.
9004802
In Commercial Distribution

  • 00304040067246 ()
9004802

  • Dental amalgam well
VP Mix HP Max Hydro RS Unflavo Reg
HENRY SCHEIN, INC.
5702993
In Commercial Distribution

  • 00304040163009 ()
5702993

  • Dental amalgam well
amalgam carrier, double ended, 15cm
NOVO SURGICAL, INC.
NS23690-1
In Commercial Distribution

  • 00842331154980 ()
NS23690-1

  • Dental amalgam well
amalgam well, stainless steel
NOVO SURGICAL, INC.
NSWA-1
In Commercial Distribution

  • 00842331153129 ()
NSWA-1

  • Dental amalgam well
T356 Amalgam Well
PDT, INC.
T356 Amalgam Well
In Commercial Distribution

  • 00813677023124 ()
T356

  • Dental amalgam well
ASSURE patient app is a component of the ASSURE WCD System and transmits information to CareStation
Kestra Medical Technologies, Inc.
80315-005
In Commercial Distribution

  • 00840241600214 ()
80315-005

  • Medical equipment clinical data interfacing software
Wire Cutting Forceps 7-1/2" (18.8cm), tungsten carbide, double action (for hard wires up to 1.6mm / soft wires up to 2.0mm)
Hayden Medical, Inc.
270-159
In Commercial Distribution

  • 00840319745984 ()
270-159

  • Wire cutter
SuperShape outer cover User Matched up to 20" wide
SPEX LIMITED
1256-2929-0SS
In Commercial Distribution

  • 09420051705456 ()
1256-2929-0SS

  • Wheelchair back rest
SuperShape Back Support User Matched up to 25" wide
SPEX LIMITED
1256-2939-0SS
In Commercial Distribution

  • 09420051705449 ()
1256-2939-0SS

  • Wheelchair back rest
CLOSED DILUTION NEBULIZER,BARREL STANDARD FLOW UP TO 12LPM
PEGASUS RESEARCH CORPORATION
301-P3100N
In Commercial Distribution

  • 612223310110 ()
  • 00612223310165 ()

  • Height: 3.5 Inch
  • Outer Diameter: 2.5 Inch
  • Length: 14.5 Inch
P3100NC

  • Nebulizing adaptor
CURAPLEX ENTRAINMENT NEBULIZER, HIGH FLOW, UP TO 40 LPM
PEGASUS RESEARCH CORPORATION
301-P3000H
In Commercial Distribution

  • 612223300210 ()
  • 00612223300265 ()

  • Outer Diameter: 2.5 Inch
  • Height: 3.5 Inch
  • Length: 14.5 Inch
P3000HC

  • Nebulizing adaptor
CLOSED DILUTION NEBULIZER, HIGH FLOW, UP TO 40 LPM
PEGASUS RESEARCH CORPORATION
301-P3100H
In Commercial Distribution

  • 00612223310264 ()

  • Length: 14.5 Inch
  • Height: 3.5 Inch
  • Outer Diameter: 2.5 Inch
P3100HC

  • Nebulizing adaptor
CLOSED DILUTION NEBULIZER, HIGH FLOW, UP TO 40 LPM
PEGASUS RESEARCH CORPORATION
P3100H
In Commercial Distribution

  • 00612223310257 ()

  • Outer Diameter: 2.5 Inch
  • Height: 3.5 Inch
  • Length: 14.5 Inch
P3100H

  • Nebulizing adaptor
CLOSED DILUTION NEBULIZER,BARREL STANDARD FLOW UP TO 12LPM
PEGASUS RESEARCH CORPORATION
P3100N
In Commercial Distribution

  • 612223310103 ()
  • 00612223310158 ()

  • Length: 14.5 Inch
  • Outer Diameter: 2.5 Inch
  • Height: 3.5 Inch
P3100N

  • Nebulizing adaptor
FLEXLAP® L-Hook, Articulating up to 70 Degrees, 35cm
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
FL1175-35
In Commercial Distribution

  • 00848657083515 ()


  • Rigid endoscopic tissue manipulation forceps, reusable
DRY BUBBLE HUMIDIFIER LOW FLOW Up To 6 LPM
WESTMED, INC.
010-104858
In Commercial Distribution

  • 10709078014274 ()
  • 00709078014277 ()


  • Non-heated respiratory humidifier
22 inch Wire Forceps, for Wires up to 6mm
Surgical Direct, Inc.
SD91427546
In Commercial Distribution

  • B382SD914275460 ()
SD91427546

  • Dressing/utility forceps, scissors-like, reusable
TRAY, LAPAROSCOPIC INSTRUMENT SET UP TO 12 CLICKLINE INSTRUMENTS
Tecomet
KSE09044
In Commercial Distribution

  • 00817766024948 ()
KSE09044

  • Device sterilization/disinfection container, reusable
Stop Closed With Applicator for Wires up to .022"
Dental Morelli Ltda
30.40.021
In Commercial Distribution

  • 07895742254988 ()
30.40.021

  • Orthodontic lock
Ball Tip Hook Universal For Wires Up To .022''
Dental Morelli Ltda
30.40.009
In Commercial Distribution

  • 07895742154790 ()
30.40.009

  • Orthodontic lock
Ball Tip Hook Straight For Wires Up To .022''
Dental Morelli Ltda
30.40.005
In Commercial Distribution

  • 07895742044190 ()
30.40.005

  • Orthodontic lock
Ball Tip Hook Left For Wires Up To .022''
Dental Morelli Ltda
30.40.004
In Commercial Distribution

  • 07895742044183 ()
30.40.004

  • Orthodontic lock
Ball Tip Hook Right For Wires Up To .022"
Dental Morelli Ltda
30.40.003
In Commercial Distribution

  • 07895742044176 ()
30.40.003

  • Orthodontic lock
Dale Foley Catheter Holder, Legband, fits up to 30"
Dale Medical Products, Inc.
316
In Commercial Distribution

  • 00817612020568 ()
  • H84103161 ()
  • 00817612020575 ()
316

  • Urinary catheter holder
Attune MAKE TO ORDER CLASSIC FEMORAL SIZER POSTERIOR UP
DEPUY ORTHOPAEDICS, INC.
2999-65-893
In Commercial Distribution

  • 10603295454458 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
Diamond knife cleaning stand, holds up to 6 knives
AMBLER SURGICAL CORP.
Diamond knife cleaning stand
In Commercial Distribution

  • 00190660211134 ()
93-211

  • Device sterilization/disinfection container, reusable
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