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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Drugs of Abuse Dip Cards 12 DRUG PANEL WITH ADULTERANTS
MCKESSON MEDICAL-SURGICAL INC.
16-DTDC12P
In Commercial Distribution

  • 20612479255337 ()
  • 10612479255323 ()
  • 40612479255348 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Drugs of Abuse Dip Cards 10 DRUG PANEL WITH ADULTERANTS
MCKESSON MEDICAL-SURGICAL INC.
16-DTDC10P
In Commercial Distribution

  • 20612479255306 ()
  • 10612479255293 ()
  • 40612479255317 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12 Panel DOA Test Dipcard;+Adulterant Test StripsOXI/SG/pH
Healgen Scientific Limited Liability Company
HDOA-6125A3
In Commercial Distribution

  • 20816490022484 ()
  • 10816490022487 ()
  • 00816490022480 ()
HDOA-6125A3

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10 Panel DOA Test Dipcard+Adulterant Test StripsOXI/SG/pH
Healgen Scientific Limited Liability Company
HDOA-1104A3
In Commercial Distribution

  • 20816490021883 ()
  • 10816490021886 ()
  • 00816490021889 ()
HDOA-4104A3

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10 Panel DOA Test Dipcard+Adulterant Test StripsOXI/SG/pH
Healgen Scientific Limited Liability Company
HDOA-4104A3
In Commercial Distribution

  • 20816490021647 ()
  • 10816490021640 ()
  • 00816490021643 ()
HDOA-4104A3

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10 Panel DOA Test Dipcard+Adulterant Test StripsOXI/SG/pH
Healgen Scientific Limited Liability Company
HDOA-7104A3
In Commercial Distribution

  • 20816490021548 ()
  • 10816490021541 ()
  • 00816490021544 ()
HDOA-7104A3

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12 Panel DOA Test Dipcard+Adulterant Test StripsOXI/SG/pH
Healgen Scientific Limited Liability Company
HDOA-1124A3
In Commercial Distribution

  • 20816490021098 ()
  • 10816490021091 ()
  • 00816490021094 ()
HDOA-1124A3

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12 Panel DOA Test Dipcard+Adulterant Test StripsOXI/SG/pH
Healgen Scientific Limited Liability Company
HDOA-6124A3
In Commercial Distribution

  • 20816490020671 ()
  • 10816490020674 ()
  • 00816490020677 ()
HDOA-6124A3

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 Panel DOA Test Dipcard +Adulterant Test StripsOXI/SG/pH
Healgen Scientific Limited Liability Company
HDOA-654A3
In Commercial Distribution

  • 20816490020497 ()
  • 10816490020490 ()
  • 00816490020493 ()
HDOA-654A3

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 Panel DOA Test Dipcard +Adulterant Test StripsOXI/SG/pH
Healgen Scientific Limited Liability Company
HDOA-254A3
In Commercial Distribution

  • 20816490020435 ()
  • 10816490020438 ()
  • 00816490020431 ()
HDOA-254A3

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 Panel DOA Test Dipcard +Adulterant Test StripsOXI/SG/pH
Healgen Scientific Limited Liability Company
HDOA-154A3
In Commercial Distribution

  • 20816490020411 ()
  • 10816490020414 ()
  • 00816490020417 ()
HDOA-154A3

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
QC Sets and Panels: Helix Elite™ SARS-CoV-2 Verification Panel
MICROBIOLOGICS INC.
ABT-001
In Commercial Distribution

  • 80845357043708 ()
ABT-001

  • SARS-CoV-2 nucleic acid IVD, control
Mylar Clad Cartridge Tube for Desk, Panel & Wall Unit 33
W. A. BAUM CO., INC.
2300
In Commercial Distribution

  • 00810010923547 ()
2300

  • Aneroid manual sphygmomanometer
No Description
PaloDEx Group Oy
GXPS-500
Not in Commercial Distribution

  • 06430035872497 ()
900469

  • Dental computed radiography digital imaging scanner
No Description
PaloDEx Group Oy
DXR50
In Commercial Distribution

  • 06430035872473 ()
900267

  • Radiography digital imaging scanner
No Description
PaloDEx Group Oy
eXam5-1
In Commercial Distribution

  • 06430035872503 ()
900467

  • Radiography digital imaging scanner
No Description
PaloDEx Group Oy
DXR60
In Commercial Distribution

  • 06430035872480 ()
900682

  • Radiography digital imaging scanner
No Description
INFIMED, INC.
3.0
Not in Commercial Distribution

  • 00858086006115 ()


  • X-ray system computer, diagnostic, general-purpose
No Description
INFIMED, INC.
Nexus DR
Not in Commercial Distribution

  • 00858086006092 ()


  • X-ray system computer, diagnostic, general-purpose
PORTABLE WORKSTATION Wirelessly Transfer Images Directly to PACS, Ultra-light, and Portable, Design tested to handle, water, dust, and splash resistance The DELWORKS FIT portable tablet workstation aims to maximize the portability and efficiency of the DELWORKS software - utilizing it anytime, anywhere.
Del Medical, Inc.
3.0
In Commercial Distribution

  • 00858340006097 ()


  • Diagnostic x-ray digital imaging system workstation
This is a CMOS sensor for the capturing of digital diagnostic x-ray images on a patient for evaluation by an appropriately trained oral healthcare professional. The Tuxedo sensor itself is a single piece comprised of the image capture components on one end, with a USB 2.0 plug on the other end. The sensor is designed to be used in conjunction with a disposable, single-use hygienic sheath as well as a positioning device to allow for proper alignment within the patient’s mouth. Images are acquired with the Tuxedo sensor by plugging it into a USB port and properly placing it in the patient’s mouth, while an operator exposes radiation toward the sensor from an approved intraoral x-ray generator.
Tuxedo Imaging LLC
TUXEDO INTRAORAL SENSOR
In Commercial Distribution

  • 00860008321374 ()
6101BR Size 2 Replacement

  • Dental digital imaging sensor, intraoral
This is a CMOS sensor for the capturing of digital diagnostic x-ray images on a patient for evaluation by an appropriately trained oral healthcare professional. The Tuxedo sensor itself is a single piece comprised of the image capture components on one end, with a USB 2.0 plug on the other end. The sensor is designed to be used in conjunction with a disposable, single-use hygienic sheath as well as a positioning device to allow for proper alignment within the patient’s mouth. Images are acquired with the Tuxedo sensor by plugging it into a USB port and properly placing it in the patient’s mouth, while an operator exposes radiation toward the sensor from an approved intraoral x-ray generator.
Tuxedo Imaging LLC
TUXEDO INTRAORAL SENSOR
In Commercial Distribution

  • 00860008321367 ()
6101BR Size 1 Replacement

  • Dental digital imaging sensor, intraoral
This is a CMOS sensor for the capturing of digital diagnostic x-ray images on a patient for evaluation by an appropriately trained oral healthcare professional. The Tuxedo sensor itself is a single piece comprised of the image capture components on one end, with a USB 2.0 plug on the other end. The sensor is designed to be used in conjunction with a disposable, single-use hygienic sheath as well as a positioning device to allow for proper alignment within the patient’s mouth. Images are acquired with the Tuxedo sensor by plugging it into a USB port and properly placing it in the patient’s mouth, while an operator exposes radiation toward the sensor from an approved intraoral x-ray generator.
Tuxedo Imaging LLC
TUXEDO INTRAORAL SENSOR
In Commercial Distribution

  • 00860008321350 ()
6100B Size 2

  • Dental digital imaging sensor, intraoral
This is a CMOS sensor for the capturing of digital diagnostic x-ray images on a patient for evaluation by an appropriately trained oral healthcare professional. The Tuxedo sensor itself is a single piece comprised of the image capture components on one end, with a USB 2.0 plug on the other end. The sensor is designed to be used in conjunction with a disposable, single-use hygienic sheath as well as a positioning device to allow for proper alignment within the patient’s mouth. Images are acquired with the Tuxedo sensor by plugging it into a USB port and properly placing it in the patient’s mouth, while an operator exposes radiation toward the sensor from an approved intraoral x-ray generator.
Tuxedo Imaging LLC
TUXEDO INTRAORAL SENSOR
In Commercial Distribution

  • 00860008321343 ()
6100B Size 1

  • Dental digital imaging sensor, intraoral
This is a CMOS sensor for the capturing of digital diagnostic x-ray images on a patient for evaluation by an appropriately trained oral healthcare professional. The Tuxedo sensor itself is a single piece comprised of the image capture components on one end, with a USB 2.0 plug on the other end. The sensor is designed to be used in conjunction with a disposable, single-use hygienic sheath as well as a positioning device to allow for proper alignment within the patient’s mouth. Images are acquired with the Tuxedo sensor by plugging it into a USB port and properly placing it in the patient’s mouth, while an operator exposes radiation toward the sensor from an approved intraoral x-ray generator.
Tuxedo Imaging LLC
TUXEDO INTRAORAL SENSOR
In Commercial Distribution

  • 00860008321336 ()
6101AR Size 2

  • Dental digital imaging sensor, intraoral
This is a CMOS sensor for the capturing of digital diagnostic x-ray images on a patient for evaluation by an appropriately trained oral healthcare professional. The Tuxedo sensor itself is a single piece comprised of the image capture components on one end, with a USB 2.0 plug on the other end. The sensor is designed to be used in conjunction with a disposable, single-use hygienic sheath as well as a positioning device to allow for proper alignment within the patient’s mouth. Images are acquired with the Tuxedo sensor by plugging it into a USB port and properly placing it in the patient’s mouth, while an operator exposes radiation toward the sensor from an approved intraoral x-ray generator.
Tuxedo Imaging LLC
TUXEDO INTRAORAL SENSOR
In Commercial Distribution

  • 00860008321329 ()
6100AR Size 1

  • Dental digital imaging sensor, intraoral
This is a CMOS sensor for the capturing of digital diagnostic x-ray images on a patient for evaluation by an appropriately trained oral healthcare professional. The Tuxedo sensor itself is a single piece comprised of the image capture components on one end, with a USB 2.0 plug on the other end. The sensor is designed to be used in conjunction with a disposable, single-use hygienic sheath as well as a positioning device to allow for proper alignment within the patient’s mouth. Images are acquired with the Tuxedo sensor by plugging it into a USB port and properly placing it in the patient’s mouth, while an operator exposes radiation toward the sensor from an approved intraoral x-ray generator.
Tuxedo Imaging LLC
TUXEDO INTRAORAL SENSOR
In Commercial Distribution

  • 00860008321312 ()
6101A Size 2

  • Dental digital imaging sensor, intraoral
This is a CMOS sensor for the capturing of digital diagnostic x-ray images on a patient for evaluation by an appropriately trained oral healthcare professional. The Tuxedo sensor itself is a single piece comprised of the image capture components on one end, with a USB 2.0 plug on the other end. The sensor is designed to be used in conjunction with a disposable, single-use hygienic sheath as well as a positioning device to allow for proper alignment within the patient’s mouth. Images are acquired with the Tuxedo sensor by plugging it into a USB port and properly placing it in the patient’s mouth, while an operator exposes radiation toward the sensor from an approved intraoral x-ray generator.
Tuxedo Imaging LLC
TUXEDO INTRAORAL SENSOR
In Commercial Distribution

  • 00860008321305 ()
6100A Size 1

  • Dental digital imaging sensor, intraoral
No Description
VAREX IMAGING CORPORATION
Nexus DR v4.17
In Commercial Distribution

  • 00854344007764 ()


  • X-ray system computer, diagnostic, general-purpose
No Description
VAREX IMAGING CORPORATION
Nexus DR, v4.16
In Commercial Distribution

  • 00854344007757 ()


  • X-ray system computer, diagnostic, general-purpose
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