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
Brazen Goods Inc.
Shortie
In Commercial Distribution

  • 00860008392121 ()
  • 00860008392152 ()


  • Oral/vaginal sex barrier, Hevea-latex
No Description
Brazen Goods Inc.
Bikini
In Commercial Distribution

  • 00860008392138 ()
  • 00860008392145 ()


  • Oral/vaginal sex barrier, Hevea-latex
No Description
Brazen Goods Inc.
Shortie
In Commercial Distribution

  • 00860008392114 ()
  • 00860008392121 ()


  • Oral/vaginal sex barrier, Hevea-latex
No Description
Brazen Goods Inc.
Bikini
In Commercial Distribution

  • 00860008392107 ()
  • 00860008392138 ()


  • Oral/vaginal sex barrier, Hevea-latex
Dry blood spot card collection kit utilizing 903 Five Spot Blood Card and Hologic Aptima Urine transport tube.
Blackfly Investments, LLC
STI collection kit
In Commercial Distribution

  • 00860008357847 ()
50428654200

  • Dried blood spot collection kit IVD
  • Sexually transmitted infection (STI) testing specimen collection kit IVD, clinical
  • Blood collection paper
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
VV330 Continuous ECG Platform is a wireless recording system intended for use by healthcare professionals for record and display of physiological data within healthcare settings or at home. This includes electrocardiogram (ECG), accelerometer data, R-R Interval and heart rate. Data is transmitted wirelessly to a separate location (such as a mobile phone) for storage and display. The VV330 Continuous ECG Platform can be configured by Authorized Persons to modify or merge or ignore any of the operational alerts, but not to set new alerts related to physiological data. The device is not intended to be used on critical care patients and is intended to supplement vital signs recording for later viewing by healthcare professionals, not to replace current standards of care. The device is an ambulatory, continuous recording system intended for use on general care patients and on patients who are 18 years of age or older.
VIVALNK, INC.
VV350
In Commercial Distribution

  • 00860008259233 ()


  • Electrocardiography telemetric monitoring system
Hydrogel Adhesive is a disposable adhesive patch containing small, thin layers of soft adhesives used for the adherence of specific sensor.
VIVALNK, INC.
A50
In Commercial Distribution

  • 00860008259226 ()


  • Dressing-fixation skin adhesive tape, non-silicone
Hydrogel Adhesive is a disposable adhesive patch containing small, thin layers of soft adhesives used for the adherence of specific sensor.
VIVALNK, INC.
B08
In Commercial Distribution

  • 00860008259219 ()


  • Dressing-fixation skin adhesive tape, non-silicone
Hydrogel Adhesive is a disposable adhesive patch containing small, thin layers of soft adhesives used for the adherence of specific sensor.
VIVALNK, INC.
A35
In Commercial Distribution

  • 00860008259202 ()


  • Dressing-fixation skin adhesive tape, non-silicone
Instant 20s Indicator consists of a vial, polypropylene cap, a silicone vented cap which serves as a base and a biological tablet produced using cellulose, and enzymes from Geobacillus stearothermophilus ATCC® 7953 For use in Monitoring Steam Sterilization Processes at 121C, 30 minutes (Gravity), 132C , 4 minutes (Pre-Vacuum) and 135C, 3 minutes (Pre-Vacuum)
True Indicating LLC
ISCS-05
In Commercial Distribution

  • 00860008246707 ()
ISCS-05

  • Chemical/physical sterilization process indicator
The ASP Device is a dual-purpose microprocessor-controlled slide preparation and staining system intended to prepare cytology samples for examination. The ASP Device is intended for use in a clinic or laboratory environment by professionals who have been trained to work with cytologic specimens.
ASP Health Inc.
REV P
In Commercial Distribution

  • 00860008222404 ()
PI-0076558

  • Microscope slide stainer IVD
Orthodontic Software
Orchestrate 3d
1
In Commercial Distribution

  • 00860008123404 ()


  • Dental milling system, CAD/CAM, chairside
NeoMatriX Wound Matrix is a sterile, wound dressing fabricated from the dermal extracellular matrix of axolotl. NeoMatriX is provided as sheets of various sizes for placement on wound beds to help manage the wound environment. This device is terminally sterilized using gamma irradiation. NeoMatriX wound matrix provides an adherent covering that protects the wound from the environment. The device is intended for one time use.
NEXTGEN BIOLOGICS INC
FDSD0103
In Commercial Distribution

  • 00860008106582 ()
FDSD0103

  • Collagen wound matrix dressing
NeoMatriX Wound Matrix is a sterile, wound dressing fabricated from the dermal extracellular matrix of axolotl. NeoMatriX is provided as sheets of various sizes for placement on wound beds to help manage the wound environment. This device is terminally sterilized using gamma irradiation. NeoMatriX wound matrix provides an adherent covering that protects the wound from the environment. The device is intended for one time use.
NEXTGEN BIOLOGICS INC
FDSD0008
In Commercial Distribution

  • 00860008106575 ()
FDSD0008

  • Collagen wound matrix dressing
NeoMatriX Wound Matrix is a sterile, wound dressing fabricated from the dermal extracellular matrix of axolotl. NeoMatriX is provided as sheets of various sizes for placement on wound beds to help manage the wound environment. This device is terminally sterilized using gamma irradiation. NeoMatriX wound matrix provides an adherent covering that protects the wound from the environment. The device is intended for one time use.
NEXTGEN BIOLOGICS INC
FDSD0010
In Commercial Distribution

  • 00860008106568 ()
FDSD0010

  • Collagen wound matrix dressing
NeoMatriX Wound Matrix is a sterile, wound dressing fabricated from the dermal extracellular matrix of axolotl. NeoMatriX is provided as sheets of various sizes for placement on wound beds to help manage the wound environment. This device is terminally sterilized using gamma irradiation. NeoMatriX wound matrix provides an adherent covering that protects the wound from the environment. The device is intended for one time use.
NEXTGEN BIOLOGICS INC
FDSD0015
In Commercial Distribution

  • 00860008106551 ()
FDSD0015

  • Collagen wound matrix dressing
NeoMatriX Wound Matrix is a sterile, wound dressing fabricated from the dermal extracellular matrix of axolotl. NeoMatriX is provided as sheets of various sizes for placement on wound beds to help manage the wound environment. This device is terminally sterilized using gamma irradiation. NeoMatriX wound matrix provides an adherent covering that protects the wound from the environment. The device is intended for one time use.
NEXTGEN BIOLOGICS INC
FDSD0102
In Commercial Distribution

  • 00860008106544 ()
FDSD0102

  • Collagen wound matrix dressing
NeoMatriX Wound Matrix is a sterile, wound dressing fabricated from the dermal extracellular matrix of axolotl. NeoMatriX is provided as sheets of various sizes for placement on wound beds to help manage the wound environment. This device is terminally sterilized using gamma irradiation. NeoMatriX wound matrix provides an adherent covering that protects the wound from the environment. The device is intended for one time use.
NEXTGEN BIOLOGICS INC
FDSD0507
Not in Commercial Distribution

  • 00860008106537 ()
FDSD0507

  • Collagen wound matrix dressing
NeoMatriX Wound Matrix is a sterile, wound dressing fabricated from the dermal extracellular matrix of axolotl. NeoMatriX is provided as sheets of various sizes for placement on wound beds to help manage the wound environment. This device is terminally sterilized using gamma irradiation. NeoMatriX wound matrix provides an adherent covering that protects the wound from the environment. The device is intended for one time use.
NEXTGEN BIOLOGICS INC
FDSD0305
Not in Commercial Distribution

  • 00860008106520 ()
FDSD0305

  • Collagen wound matrix dressing
NeoMatriX Wound Matrix is a sterile, wound dressing fabricated from the dermal extracellular matrix of axolotl. NeoMatriX is provided as sheets of various sizes for placement on wound beds to help manage the wound environment. This device is terminally sterilized using gamma irradiation. NeoMatriX wound matrix provides an adherent covering that protects the wound from the environment. The device is intended for one time use.
NEXTGEN BIOLOGICS INC
FDSD0203
In Commercial Distribution

  • 00860008106513 ()
FDSD0203

  • Collagen wound matrix dressing
NeoMatriX Wound Matrix is a sterile, wound dressing fabricated from the dermal extracellular matrix of axolotl. NeoMatriX is provided as sheets of various sizes for placement on wound beds to help manage the wound environment. This device is terminally sterilized using gamma irradiation. NeoMatriX wound matrix provides an adherent covering that protects the wound from the environment. The device is intended for one time use.
NEXTGEN BIOLOGICS INC
FDSD0307
Not in Commercial Distribution

  • 00860008106506 ()
FDSD0307

  • Collagen wound matrix dressing
The Strike Force from Power Soccer Shop is the first wheelchair designed specifically for power soccer! Designed with a low center of gravity and wide wheelbase, the Strike Force is able to move with more agility and spin kick with more power than any other power wheelchair in the world! Equipped with top-notch components and built on a durable steel frame, this chair is ready for the rigors of elite competition.
Northern Engineering and Manufacturing, Inc.
1633
In Commercial Distribution

  • 00860008065407 ()


  • Wheelchair, electric-motor-driven, occupant-controlled, powered-steering, non-collapsible
Silicone Foley Catheter Insertion Kit - 12Fr
Dynarex Corporation
10004
In Commercial Distribution

  • 00860008059581 ()
  • 00860008059598 ()


  • Urethral catheterization support kit, urinary drainage
Silicone Foley Catheter Insertion Kit - 14 Fr
Dynarex Corporation
10003
In Commercial Distribution

  • 00860008059505 ()
  • 00860008123206 ()


  • Urethral catheterization support kit, urinary drainage
Kinos Axiom Flat Top Talar Implant, Size 5, Right
Restor3d, Inc.
2831.0215
Not in Commercial Distribution

  • 00860007995194 ()


  • Coated ankle tibia prosthesis
Kinos Axiom Flat Top Talar Implant, Size 4, Right
Restor3d, Inc.
2831.0214
Not in Commercial Distribution

  • 00860007995187 ()


  • Coated ankle tibia prosthesis
Kinos Axiom Flat Top Talar Implant, Size 3, Right
Restor3d, Inc.
2831.0213
Not in Commercial Distribution

  • 00860007995170 ()


  • Coated ankle tibia prosthesis
Kinos Axiom Flat Top Talar Implant, Size 2, Right
Restor3d, Inc.
2831.0212
Not in Commercial Distribution

  • 00860007995163 ()


  • Coated ankle tibia prosthesis
Kinos Axiom Flat Top Talar Implant, Size 1, Right
Restor3d, Inc.
2831.0211
Not in Commercial Distribution

  • 00860007995156 ()


  • Coated ankle tibia prosthesis
Kinos Axiom Flat Top Talar Implant, Size 5, Left
Restor3d, Inc.
2831.0115
Not in Commercial Distribution

  • 00860007995149 ()


  • Coated ankle tibia prosthesis
Kinos Axiom Flat Top Talar Implant, Size 4, Left
Restor3d, Inc.
2831.0114
Not in Commercial Distribution

  • 00860007995132 ()


  • Coated ankle tibia prosthesis
Kinos Axiom Flat Top Talar Implant, Size 3, Left
Restor3d, Inc.
2831.0113
Not in Commercial Distribution

  • 00860007995125 ()


  • Coated ankle tibia prosthesis
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