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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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UNO Pump 15 Day Rechargeable - 00849405001614

The Genadyne UNO is a single use Negative Pressure Wound Therapy (NPWT) Unit designed for moderate to low severity wounds. The Genadyne UNO NPWT Unit has a pre-determined lifespan. The unit features an interface panel which provides alert and information signals and selectable therapy options. This unit provides negative pressure at either 80 mmHg or 125 mmHg, and offers selections of Continuous Mode at 80mmHg / 30mmHg or 125mmHg / 30mmHg in Variable Mode. The Genadyne UNO Therapy Kits include a therapy unit, 70 cc canisters, USB charger, USB cable and sterile dressing kits. Dressing kits and canisters for the Genadyne UNO could be provided separately. Dressing should be changed in line with standard wound dressing guidelines, typically every 3 days. More frequent changes may be required depending on level of exudate, condition of dressing, wound type/sizes, orientation of the dressing, environmental considerations or other patient considerations; e.g. when UNO is used on infected wounds.
GENADYNE BIOTECHNOLOGIES INC.
U-S00R5
In Commercial Distribution

  • 00849405001614 ()


  • Negative-pressure wound therapy system, electric, single-use

UNO Pump 7 Day Rechargeable - 00849405001607

The Genadyne UNO is a single use Negative Pressure Wound Therapy (NPWT) Unit designed for moderate to low severity wounds. The Genadyne UNO NPWT Unit has a pre-determined lifespan. The unit features an interface panel which provides alert and information signals and selectable therapy options. This unit provides negative pressure at either 80 mmHg or 125 mmHg, and offers selections of Continuous Mode at 80mmHg / 30mmHg or 125mmHg / 30mmHg in Variable Mode. The Genadyne UNO Therapy Kits include a therapy unit, 70 cc canisters, USB charger, USB cable and sterile dressing kits. Dressing kits and canisters for the Genadyne UNO could be provided separately. Dressing should be changed in line with standard wound dressing guidelines, typically every 3 days. More frequent changes may be required depending on level of exudate, condition of dressing, wound type/sizes, orientation of the dressing, environmental considerations or other patient considerations; e.g. when UNO is used on infected wounds.
GENADYNE BIOTECHNOLOGIES INC.
U-S00R4
In Commercial Distribution

  • 00849405001607 ()


  • Negative-pressure wound therapy system, electric, single-use

UNO 30 Therapy Kit 10x10 - 00849405001478

The Genadyne UNO is a single use Negative Pressure Wound Therapy (NPWT) Unit designed for moderate to low severity wounds. The Genadyne UNO NPWT Unit has a pre-determined lifespan. The unit features an interface panel which provides alert and information signals and selectable therapy options. This unit provides negative pressure at either 80 mmHg or 125 mmHg, and offers selections of Continuous Mode at 80mmHg / 30mmHg or 125mmHg / 30mmHg in Variable Mode. The Genadyne UNO Therapy Kits include a therapy unit, 70 cc canisters, USB charger, USB cable and sterile dressing kits. Dressing kits and canisters for the Genadyne UNO could be provided separately. Dressing should be changed in line with standard wound dressing guidelines, typically every 3 days. More frequent changes may be required depending on level of exudate, condition of dressing, wound type/sizes, orientation of the dressing, environmental considerations or other patient considerations; e.g. when UNO is used on infected wounds.
GENADYNE BIOTECHNOLOGIES INC.
U-S1010-6
In Commercial Distribution

  • 00849405001478 ()


  • Negative-pressure wound therapy system, electric, single-use

UNO 7 Therapy Kit 10x10 - 00849405000549

The Genadyne UNO is a single use Negative Pressure Wound Therapy (NPWT) Unit designed for moderate to low severity wounds. The Genadyne UNO NPWT Unit has a pre-determined lifespan. The unit features an interface panel which provides alert and information signals and selectable therapy options. This unit provides negative pressure at either 80 mmHg or 125 mmHg, and offers selections of Continuous Mode at 80mmHg / 30mmHg or 125mmHg / 30mmHg in Variable Mode. The Genadyne UNO Therapy Kits include a therapy unit, 70 cc canisters, USB charger, USB cable and sterile dressing kits. Dressing kits and canisters for the Genadyne UNO could be provided separately. Dressing should be changed in line with standard wound dressing guidelines, typically every 3 days. More frequent changes may be required depending on level of exudate, condition of dressing, wound type/sizes, orientation of the dressing, environmental considerations or other patient considerations; e.g. when UNO is used on infected wounds.
GENADYNE BIOTECHNOLOGIES INC.
U-S1010-4
In Commercial Distribution

  • 00849405000549 ()


  • Negative-pressure wound therapy system, electric, single-use

UNO 15 Therapy Kit 10x10 - 00849405000532

The Genadyne UNO is a single use Negative Pressure Wound Therapy (NPWT) Unit designed for moderate to low severity wounds. The Genadyne UNO NPWT Unit has a pre-determined lifespan. The unit features an interface panel which provides alert and information signals and selectable therapy options. This unit provides negative pressure at either 80 mmHg or 125 mmHg, and offers selections of Continuous Mode at 80mmHg / 30mmHg or 125mmHg / 30mmHg in Variable Mode. The Genadyne UNO Therapy Kits include a therapy unit, 70 cc canisters, USB charger, USB cable and sterile dressing kits. Dressing kits and canisters for the Genadyne UNO could be provided separately. Dressing should be changed in line with standard wound dressing guidelines, typically every 3 days. More frequent changes may be required depending on level of exudate, condition of dressing, wound type/sizes, orientation of the dressing, environmental considerations or other patient considerations; e.g. when UNO is used on infected wounds.
GENADYNE BIOTECHNOLOGIES INC.
U-S1010-5
In Commercial Distribution

  • 00849405000532 ()


  • Negative-pressure wound therapy system, electric, single-use

Adventure Medical Kits - 00707708100161

Mountain Series Daytripper Bandage Materials 5 - Bandage, Adhesive, Fabric, 1" x 3" 3 - Bandage, Adhesive, Fabric, Knuckle 4 - Bandage, Butterfly Closure 2 - Dressing, Gauze, Sterile, 2" x 2", Pkg./2 2 - Dressing, Gauze, Sterile, 4" x 4", Pkg./2 2 - Dressing, Non-Adherent, Sterile, 2" x 3" Bleeding 1 - Gloves, Nitrile (Pair), Hand Wipe 1 - Trauma Pad, 5" x 9" Blister / Burn 1 - Moleskin, Pre-Cut & Shaped (14 pieces) Fracture / Sprain 1 - Bandage, Elastic with Velcro, 2" Instrument 2 - Safety Pins 1 - Splinter Picker/Tick Remover Forceps Medical Information 1 - Comp. Guide to Wilderness & Travel Medicine Medication 2 - After Bite Wipe 2 - Antihistamine (Diphenhydramine 25 mg) 2 - Aspirin (325 mg), Pkg./2 2 - Diamode (Loperamide HCI 2 mg), Pkg./1 3 - Ibuprofen (200 mg), Pkg./2 Wound Care 4 - Antiseptic Wipe 2 - Alcohol Swab 1 - Cotton Tip Applicator, Pkg./2 1 - Syringe, Irrigation, 10 cc, 18 Gauge Tip 1 - Tape, 1" x 10 Yards 1 - Skin Tac Adhesive Wipes 3 - Triple Antibiotic Ointment, Single Use
Adventure Ready Brands
1
In Commercial Distribution

  • 00707708100161 ()
0100-0116

  • First aid kit, medicated

ENDOCEM MTA - 08800071200079

1. Description: ENDOCEM MTA was developed for regenerative endodontic treatment such as partial pulpotomy; and is designed to prevent irritation of pulp and secondary infections. It is a powder type. Use with saline or distilled water. The mixing ratio is 300 mg / 0.12 cc. 2. Principle of operation: ENDOCEM MTA is natural pure cement based endodontic material. product based on the science of pozzolan reactions. It has a fast setting time that allows for resin bonding to occur immediately after setting. It maintains its integrity in less than ideal clinical situations, including contamination with blood or saliva and presence of inflammation or infection. 3. Storage conditions: 1) The product shall be kept out of direct sunlight and stored at room temperature. It shall not be stored in a place with high temperature and humidity. 2) The remaining material shall be disposed of. 4. Shelf life: 3 years from manufacture date if storage conditions are followed.
MARUCHI
ENDOCEM MTA
In Commercial Distribution

  • 08800071200079 ()


  • Hygroscopic dental cement

SIR-Spheres microspheres - M425SIRY0010

SIR-Y001 (3Gbq/5ml): SIR-Spheres Y90 resin microspheres consist of biocompatible resin microspheres containing yttrium-90 with a size between 20 and 60 microns in diameter. Each vial contains 3 GBq of Y90 ± 10% (at the time of calibration) in a total of 5 cc water for injection. Yttrium-90 is a high-energy pure beta-emitting isotope with no primary gamma emission. The maximum energy of the beta particles is 2.27MeV with a mean of 0.93MeV. The maximum range of emissions in tissue is 11mm with a mean of 2.5mm. This is a brachytherapy product considered to be a sealed source device. The yttrium-90 has a purity specification of 999,900 ppm at reference, at (or after) time of manufacture of SIR-Spheres microspheres. The half-life is 64.1 hours. In use requiring the isotope to decay to infinity, 94% of the radiation is delivered in 11 days leaving only background radiation with no therapeutic value. SIR-Spheres microspheres themselves are a permanent implant. Each device is for single patient use.
SIRTEX MEDICAL PTY LTD
SIR-Y001
Not in Commercial Distribution

  • M425SIRY0010 ()

  • Total Volume: 5 Milliliter


  • Manual brachytherapy source, permanent implant

Angios Classic Angiographic Convenience Kit - 00885672103392

Angiographic Convenience Kit, 6F
Oscor Inc.
ANG4-0442
In Commercial Distribution

  • 00885672103392 ()

  • Flow Rate: JR: 32 mL/sec, JL: 29 mL/sec, PT: 33 mL/sec
  • Recommended Pressure Limit: 1200 psi max.
  • Guidewire - Length: 150 cm, OD: 0.035 in
  • Adelante Sigma Introducer, 6F, Length: 10 cm, Needle 18 G, Syringe 10 cc
  • JL 4.0/120 cm, JR 4.0/120 cm, Pigtail 145°/120 cm
  • Pigtail Side Holes: 5
  • Adelante Sigma Introducer Guidewire - Length: 50 cm, OD: 0.038 in
  • Maximum Recommended Guidewire 0.038 in
ANG4-0442

  • Angiographic catheter, single-use

Angios Classic Angiographic Convenience Kit - 00885672101916

Angiographic Convenience Kit, 5F
Oscor Inc.
ANG4-0240
In Commercial Distribution

  • 00885672101916 ()

  • Recommended Pressure Limit: 1200 psi max.
  • Adelante Sigma Introducer Guidewire - Length: 50 cm, OD: 0.038 in
  • Maximum Recommended Guidewire 0.038 in
  • Guidewire - Length: 150 cm, OD: 0.035 in
  • JL 4.0/110 cm, JR 4.0/110 cm, Pigtail 145°/120 cm
  • Adelante Sigma Introducer, 5F, Length: 10 cm, Needle 18 G, Syringe 10 cc
  • Pigtail Side Holes: 5
  • Flow Rate: JR: 28 mL/sec, JL: 28 mL/sec, PT: 29 mL/sec
ANG4-0240

  • Angiographic catheter, single-use
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