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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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Durepair™ 12.5cm x 20.0cm (5" x 8")
TEI BIOSCIENCES INC.
62158
In Commercial Distribution


  • Length: 12.5 Centimeter
  • Width: 20 Centimeter
  • Length: 5 Inch
  • Width: 8 Inch
62158

  • Dura mater graft, bovine
Durepair™ 2.5cm x 7.5cm (1" x 3")
TEI BIOSCIENCES INC.
62106
In Commercial Distribution


  • Length: 7.5 Centimeter
  • Width: 2.5 Centimeter
  • Length: 3 Inch
  • Width: 1 Inch
62106

  • Dura mater graft, bovine
DURA 62158 SUBSTITUTE DUREPAIR 5X8IN NCE
MEDTRONIC PS MEDICAL, INC.
62158
Not in Commercial Distribution

  • 00643169063907 ()

  • Width: 12.5 Centimeter
  • Length: 20.3 Centimeter


  • Dura mater graft, bovine
No Description
MANI, INC.
9
In Commercial Distribution

  • 04546951500399 ()
  • 14546951500396 ()
9

  • Polyester suture, non-bioabsorbable, multifilament
Tinted Glow Powder
JBC and Company
9
In Commercial Distribution

  • D85109 ()
9

  • Dental appliance fabrication material, resin
Powdered Sterile Latex Surgical Gloves
Beijing Reagent Latex Products Factory
9
In Commercial Distribution

  • 16936610210304 ()
  • 06936610210307 ()
  • 26936610210301 ()


  • Hevea-latex surgical glove, powdered
Powder free Sterile Latex Surgical Gloves
Beijing Reagent Latex Products Factory
9
In Commercial Distribution

  • 16936610210212 ()
  • 06936610210215 ()
  • 26936610210219 ()


  • Hevea-latex surgical glove, non-powdered, non-antimicrobial
eRAD PACS v9
Erad, Inc.
9
In Commercial Distribution

  • 00866994000255 ()


  • Radiological PACS software
The uLab Systems uDesign is orthodontic diagnosis and treatment simulation software for use by dental professionals. uDesign imports patient 3-D digital scans and allows the user to diagnose the orthodontic treatment needs of the patient and rapidly develop a treatment plan. The output of the treatment plan may be downloaded as files in standard stereolithographic (STL) format for fabrication of dental casts, which may be used to fabricate sequential aligner trays or retainers.
Ulab Systems, Inc.
9
In Commercial Distribution

  • 00860461001783 ()
FG0064

  • Dental milling system, CAD/CAM, laboratory
No Description
Bio-Research Associates, Inc.
9
In Commercial Distribution

  • 00860003499948 ()


  • Jaw physiology evaluation system
ProOcular Daily Disposable Contact Lens Power -9
CARLSBAD TECHNOLOGY INC.
-9
Not in Commercial Distribution

  • 40816816880631 ()
  • 30816816880634 ()
  • 10816816880630 ()
  • 00816816880633 ()


  • Soft corrective contact lens, daily-disposable
The PureWay® Sharps Collector container is blow molded with High Density Polyethylene plastic. The containers are identical except for capacity. The device has a circular opening at the top with an insert to prevent hand access and items from falling out. The insert is made of Low Density Polyethylene plastic, is also circular limiting the opening to 1.25 inches. The opening allows for a vertical sharps drop. Once the PureWay® Sharps Collector container is full, the cap is placed on top of the opening and screwed close for a tight seal. The containers are designed to contain and hold sharps such as angio-caths, blood needles, lancets, cap needles, and various sized syringes. The shape of the container will be rectangular and the only access to the container is through the screw top opening or aperture. In summary, all PureWay® Sharps Collector containers are blow molded using High Density Polyethylene plastic, non-sterile, disposable, sharps containers (infectious waste container). All the devices allow for onehanded disposal of sharps and offer a means of closure. 2 gallon twin pack sharps disposal ship back system (Includes two 2 gallon sharps container, box, bag, zip tie).
PUREWAY COMPLIANCE
9
In Commercial Distribution

  • 10853022008069 ()
  • 00853022008062 ()

  • Total Volume: 2.0 Gallon
40022

  • Sharps container
9" Alligator Rongeur
MEDISURGE LLC
9"
In Commercial Distribution

  • G611BIO110430 ()
BIO-1-1043

  • Orthopaedic joint/limb rongeur
Dental implant planning software
Dental Wings GmbH
9
Not in Commercial Distribution

  • D835CDX202 ()
  • D835CDX1 ()
  • D835CDX201 ()
  • D835CDX200 ()


  • Diagnostic x-ray digital imaging system workstation
Dental CADCAM Software
Dental Wings Inc
9
In Commercial Distribution

  • D840DWOSCAD1 ()


  • Dental milling system, CAD/CAM, laboratory
No Description
Ad-Tech Medical Instrument Corporation
9
In Commercial Distribution

  • 00841823109705 ()
BF08R-SP61X-0C3

  • Depth electrode
TIDI Positioning Aid Kits Kit, Various Sizes 12 per Set
TIDI PRODUCTS, LLC
9
Not in Commercial Distribution

  • 00618125168231 ()


  • Multifunction body cushion
SE CUTTING INSTRUMENT #9
NORDENT MANUFACTURING INC
9
In Commercial Distribution

  • 00840018633728 ()


  • Margin finishing dental file/rasp, reusable
WebPAX® is intended for use in the communication and storage of medical images. WebPAX® is also intended for use as a comprehensive solution to view, optimize, and post-process diagnostic medical images as an aid to physicians and other healthcare professionals in the evaluation of digital imaging examinations.
HEART IMAGING TECHNOLOGIES, LLC
9
In Commercial Distribution

  • B127WP90 ()
n/a

  • Medical image management system
PACS Device
Les Systèmes Médicaux Intelerad Incorporée
9
In Commercial Distribution

  • B228INTELEHEART0 ()


  • Radiological PACS software
No Description
Chemoment Materials Co., Ltd.
9
In Commercial Distribution

  • 06976009589997 ()


  • Silicone dental impression material
Berman airway is used to establish the airway and prevent the tongue fall and the airway block.
XIAMEN COMPOWER MEDICAL TECH. CO., LTD
9#
In Commercial Distribution

  • 26946430401261 ()
  • 16946430401264 ()
  • 06946430401267 ()


  • Oropharyngeal airway, single-use
Berman airway is used to establish the airway and prevent the tongue fall and the airway block.
XIAMEN COMPOWER MEDICAL TECH. CO., LTD
9#
In Commercial Distribution

  • 26946430401087 ()
  • 16946430401080 ()
  • 06946430401083 ()


  • Oropharyngeal airway, single-use
GLASS VAN STAINLESS STEEL STERILE SURGICAL BLADE #9 INDIVIDUALLY PACKED MYCO REORDER # 2003-09
NIRAJ INDUSTRIES PRIVATE LIMITED
#9
In Commercial Distribution

  • 28904233119835 ()
  • 18904233119838 ()
  • 58904233119836 ()
  • 08904233119831 ()
01983

  • Manual scalpel blade, single-use
Enterprise
DEXIS LLC
9
In Commercial Distribution

  • EKAV101034120 ()
PLU238

  • Radiology information system application software
Animal
DEXIS LLC
9
In Commercial Distribution

  • EKAV101034090 ()
PLU235

  • Radiology information system application software
US & International
DEXIS LLC
9
In Commercial Distribution

  • EKAV101034110 ()
PLU349

  • Radiology information system application software
Forensic
DEXIS LLC
9
In Commercial Distribution

  • EKAV101034080 ()
PLU236

  • Radiology information system application software
No Description
Raysearch Laboratories AB (Publ)
9
In Commercial Distribution

  • 07350002010174 ()


  • Radiation therapy software
KIT, RECTANGLE. Includes: 126-00-001 - RECTANGLE, 6" x 4" x .50" (00810050243834), 126-00-002 - RECTANGLE, 6" x 4" x 1 " (00810050243841), 126-00-003 - RECTANGLE, 6" x 4" x 1.50" (00810050243858), 126-00-004 - RECTANGLE, 6" x 4" x 2" (00810050243865)
DOMICO MED-DEVICE, LLC
9
In Commercial Distribution

  • 00810050243933 ()


  • Multifunction body cushion
  • Radiological general body-part positioner
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