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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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The CarePath system facilitates evaluations measuring urine output. It consists of the CarePath device, accompanying documents, and training. The system: • Measures and calculates flow rate and volume from urination data • Automatically transmits urination data to a secure location • Creates and provides uroflow reports to healthcare providers The intended operator of the CarePath device is the patient. The CarePath system has no user-serviceable components. This system is not to be serviced or maintained by the user. The intended environments are hospitals, clinics, doctor’s offices and the patient’s home.
I/O Urology Corp.
DCDUFD-001M
In Commercial Distribution

  • 00860010862209 ()


  • Urine flowmeter, reusable
Pro - Direct Adult Mac 4 Blade
One-AI Healthcare, Inc
Pro - Direct Adult Mac 4 Blade
In Commercial Distribution

  • 00860010859766 ()


  • Video intubation laryngoscope blade
Pro - Angulated Adult Size 4 Blade
One-AI Healthcare, Inc
Pro - Angulated Adult Size 4 Blade
In Commercial Distribution

  • 00860010859759 ()


  • Video intubation laryngoscope blade
Pro - Direct Adult Mac 3 Blade
One-AI Healthcare, Inc
Pro - Direct Adult Mac 3 Blade
In Commercial Distribution

  • 00860010859742 ()


  • Video intubation laryngoscope blade
Pro - Angulated Adult Size 3 Blade
One-AI Healthcare, Inc
Pro - Angulated Adult Size 3 Blade
In Commercial Distribution

  • 00860010859735 ()


  • Video intubation laryngoscope blade
Pro - Pediatric Size 2 Blade
One-AI Healthcare, Inc
Pro - Pediatric Size 2 Blade
In Commercial Distribution

  • 00860010859728 ()


  • Video intubation laryngoscope blade
Pro - Neonatal Size 1 Blade
One-AI Healthcare, Inc
Pro - Neonatal Size 1 Blade
In Commercial Distribution

  • 00860010859711 ()
3010001

  • Video intubation laryngoscope blade
OneScope Pro Video Laryngoscope
One-AI Healthcare, Inc
OneScope Pro Video Laryngoscope
In Commercial Distribution

  • 00860010859704 ()


  • Video intubation laryngoscope handle/monitor
Everyday Carry Tourniquet Wide (ETQ-W) - Gen 1 - 1.5" - Black
Snakestaff Systems, LLC
ETQ-W-G1
In Commercial Distribution

  • 00860010714812 ()
ETQ-W

  • Limb tourniquet, manual, single-use
Everyday Carry Tourniquet (ETQ) - Gen 1 - 1.0" - Black
Snakestaff Systems, LLC
ETQ-G1
In Commercial Distribution

  • 00860010714805 ()
ETQ

  • Limb tourniquet, manual, single-use
VECTR - Video Endoscopic Carpal Tunnel Release System
Rafael Medical Devices, LLC
5200-01
In Commercial Distribution

  • 00860010523902 ()


  • Hand ligament surgical release instrument
LuxCreo Dental Clear Aligner Resin is a liquid light-curing resin product indicated for the three-dimensional fabrication of orthodontic and dental appliances such as aligners and retainers.
Luxcreo Inc
1kg/Bottle
In Commercial Distribution

  • 00860010425459 ()


  • Dental appliance fabrication material, thermoplastic
LuxCreo Dental Clear Aligner Resin is a liquid light-curing resin product indicated for the three-dimensional fabrication of orthodontic and dental appliances such as aligners and retainers.
Luxcreo Inc
0.5kg/Bottle
In Commercial Distribution

  • 00860010425442 ()


  • Dental appliance fabrication material, thermoplastic
LuxCreo Dental Night Guard Resin is a liquid light-curing resin product indicated for the Three-Dimensional fabrication of orthodontic and dental appliances such as mouthguards, nightguards, splints, and repositioners.
Luxcreo Inc
5kg/Bottle
In Commercial Distribution

  • 00860010425435 ()


  • Dental appliance fabrication material, thermoplastic
LuxCreo Dental Night Guard Resin is a liquid light-curing resin product indicated for the Three-Dimensional fabrication of orthodontic and dental appliances such as mouthguards, nightguards, splints, and repositioners.
Luxcreo Inc
1kg/Bottle
In Commercial Distribution

  • 00860010425428 ()


  • Dental appliance fabrication material, thermoplastic
LuxCreo Dental Night Guard Resin is a liquid light-curing resin product indicated for the Three-Dimensional fabrication of orthodontic and dental appliances such as mouthguards, nightguards, splints, and repositioners.
Luxcreo Inc
0.5kg/Bottle
In Commercial Distribution

  • 00860010425411 ()


  • Dental appliance fabrication material, thermoplastic
Stern Gills Scissors with Extra Thin 10mm Blades Angled Forward Sharp Tips
Fischer Surgical, Inc.
Stern Gill Scissors Extra Thin 10mm
In Commercial Distribution

  • 00860010356258 ()
FS7505

  • Intraocular scissors, conventional-hinge, reusable
Nevyas MICS Capsulorrhexis Forceps, Cystotome shaped tips, ultra delicate shanks/tips, max jaw opening 1.75mm
Fischer Surgical, Inc.
Nevyas MICS Capsulorrhexis Forceps
In Commercial Distribution

  • 00860010356241 ()
FF6561

  • Ophthalmic soft-tissue manipulation forceps, tweezers-like, reusable
Nitrile Powder Free Examination Glove, Single Use, 6.2 gram, Large, Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Black)
Safe.R World Corporation
6.2 gram, Large, Black
In Commercial Distribution

  • 00860010239094 ()
  • 00860010239087 ()
  • 00860010937501 ()
NGPF62BL1200

  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
Nitrile Powder Free Examination Glove, Single Use, 6.2 gram, X-Large Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Black)
Safe.R World Corporation
6.2 gram, X-Large, Black
In Commercial Distribution

  • 00860010239070 ()
  • 00860010239056 ()
  • 00860010937518 ()
NGPF62BXL1201

  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
Glove PF Nitrile Exam Black XX-Large10/100
IP Products
IPNGK-805
In Commercial Distribution

  • 00860010093740 ()
  • 00860010093764 ()
  • 00860010093757 ()
IPNGK-805

  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
No Description
Armor Dental Corp.
73208
In Commercial Distribution

  • 00860010019641 ()


  • Hand-held dental retractor
No Description
Armor Dental Corp.
73207
In Commercial Distribution

  • 00860010019634 ()


  • Hand-held dental retractor
No Description
Armor Dental Corp.
60800
In Commercial Distribution

  • 00860010019627 ()


  • Hand-held dental retractor
No Description
Armor Dental Corp.
73200
In Commercial Distribution

  • 00860010019610 ()


  • Hand-held dental retractor
No Description
Armor Dental Corp.
73201
In Commercial Distribution

  • 00860010019603 ()


  • Hand-held dental retractor
Zeitels Universal Modular Glottiscope System is a Modular Laryngoscope for Vocal surgery. This product contains 3 blades of different sizes and one handle. Also included is a suction Cannula, a light carrier, and a fiberoptic light cable.
Endocraft, LLC
UMG100A
In Commercial Distribution

  • 00860009975149 ()
UMG100A

  • Laryngoscope handle, reusable
  • Laryngoscope blade, reusable
Zeitels Intubation Scope. Slotted speculum to pass tube through trachea with Fiber optic carrier. Modular handle.
Endocraft, LLC
IS77
In Commercial Distribution

  • 00860009975125 ()
IS77

  • Rigid intubation laryngoscope, reusable
  • Laryngoscope handle, reusable
European Angled Horizontal Handle Assembly for use with Storz-stlye scopes to connect to Suspension Gallows
Endocraft, LLC
HHA-EURO
In Commercial Distribution

  • 00860009975118 ()
HHA-EURO

  • Laryngoscope handle, reusable
Zeitels Slim Universal Modular Glottiscope System is a Modular Laryngoscope for Vocal surgery. This product contains 3 blades of different sizes and one handle. Also included is a suction Cannula, a light carrier, and a fiberoptic light cable. It is slimmer and designed geometrically to enhance access to tighter surgical sites.
Endocraft, LLC
SlimUMG100
In Commercial Distribution

  • 00860009975101 ()
SlimUMG100

  • Laryngoscope handle, reusable
  • Laryngoscope blade, reusable
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