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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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Semi-Rigid Curette 3mm OD
Coopersurgical, Inc.
MX603
In Commercial Distribution

  • 20888937000874 ()
  • 00888937000870 ()

  • Outer Diameter: 3 Millimeter


  • Endometrial biopsy kit
Flexible Curette 5mm OD
Coopersurgical, Inc.
MX505
In Commercial Distribution

  • 20888937000645 ()
  • 00888937000641 ()

  • Outer Diameter: 5 Millimeter


  • Endometrial biopsy kit
The Rabbit FluoroDetector FITC with FluoroMounter kit is intended for the detection of antigens in paraffin-embedded tissue, cryostat sections, blood smears, cytosmears, and cell preparations.
BIO SB, INC.
100 ml
In Commercial Distribution

  • B502BSB03170 ()
BSB 0317

  • Immunohistochemistry antibody detection IVD, kit, enzyme immunohistochemistry
The Rabbit FluoroDetector FITC with FluoroMounter kit is intended for the detection of antigens in paraffin-embedded tissue, cryostat sections, blood smears, cytosmears, and cell preparations.
BIO SB, INC.
50 ml
In Commercial Distribution

  • B502BSB03160 ()
BSB 0316

  • Immunohistochemistry antibody detection IVD, kit, enzyme immunohistochemistry
The Rabbit FluoroDetector FITC with FluoroMounter kit is intended for the detection of antigens in paraffin-embedded tissue, cryostat sections, blood smears, cytosmears, and cell preparations.
BIO SB, INC.
15 ml
In Commercial Distribution

  • B502BSB03150 ()
BSB 0315

  • Immunohistochemistry antibody detection IVD, kit, enzyme immunohistochemistry
Sonigel 1863 (1 x 1 gallon)
METTLER ELECTRONICS CORP.
1863
In Commercial Distribution

  • 00816864020326 ()
1863

  • Transcutaneous electrical stimulation electrode, single-use
Flexible Curette 7mm OD
Coopersurgical, Inc.
MX507
In Commercial Distribution

  • 20888937000669 ()
  • 00888937000665 ()

  • Outer Diameter: 7 Millimeter


  • Endometrial biopsy kit
Flexible Curette 6mm OD
Coopersurgical, Inc.
MX506
In Commercial Distribution

  • 20888937000652 ()
  • 00888937000658 ()

  • Outer Diameter: 6 Millimeter


  • Endometrial biopsy kit
Flexible Curette 4mm OD
Coopersurgical, Inc.
MX504
In Commercial Distribution

  • 20888937000638 ()
  • 00888937000634 ()

  • Outer Diameter: 4 Millimeter


  • Endometrial biopsy kit
Flexible Curette 3mm OD
Coopersurgical, Inc.
MX503
In Commercial Distribution

  • 20888937000621 ()
  • 00888937000627 ()

  • Outer Diameter: 3 Millimeter


  • Endometrial biopsy kit
The VORTRAN GO2VENT with PEEP Valve is to be used by properly trained personnel to deliver emergency, short-term, constant flow, pressure-cycled ventilatory support on patients weighing 10 kg and above.
VORTRAN MEDICAL TECHNOLOGY 1, INC
6200
In Commercial Distribution

  • 20637320062001 ()
  • 10637320062004 ()
6200

  • Pulmonary resuscitator, pneumatic, single-use
KIRSCHNER WIRE
Zimmer GmbH
290.16.280
In Commercial Distribution

  • 00889024298323 ()
290.16.280

  • Internal orthopaedic fixation system, cerclage wire/cable, non-sterile
BELLOW BLUE WITH VENTIL AND CONNECTION M8
SONTEC INSTRUMENTS, INC.
04-11020-10
Not in Commercial Distribution

  • B0990411020100 ()


  • ENT powder applicator
The dermaPACE console and applicator shipped together. An assembly of devices designed to provide high-energy, spark-gap generated (electrohydraulic) extracorporeal shock wave intended to treat diabetic foot ulers.
Sanuwave, Inc.
DEP0330/DAP0332
In Commercial Distribution

  • 00812265010225 ()


  • Dermatological extracorporeal shock wave therapy system
Enzymatic detergents used to clean medical instruments.
Ruhof Corporation
34501-07
In Commercial Distribution

  • 00810929014879 ()
  • 00810929014787 ()


  • Medical device cleaning agent
Enzymatic detergents used to clean medical instruments.
Ruhof Corporation
34501-13
In Commercial Distribution

  • 00810929010550 ()
  • 00810929010543 ()


  • Medical device cleaning agent
Enzymatic detergents used to clean medical instruments.
Ruhof Corporation
34501-16
In Commercial Distribution

  • 00810929010345 ()
  • 00810929010338 ()


  • Medical device cleaning agent
PACSCore VNA archive with remote, remote backup, and optional local repositories, and ConnectWeb on remote archive
Radius
7
In Commercial Distribution

  • B295VNA70 ()


  • Radiological PACS software
No Description
INTELLIGENT HEARING SYSTEMS CORP.
M015453
In Commercial Distribution

  • 00817020020600 ()


  • Earphone, insert
PEDICLE AWL, STRAIGHT WITH TROCAR
Si-Bone Inc.
502206
In Commercial Distribution

  • 00810055524747 ()


  • Sacroiliac joint transarticular fixation/arthrodesis implantation kit
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