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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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EQUIPMENT RAIL 10"
SKYTRON LLC
H8-200-02
In Commercial Distribution

  • 10841736114893 ()


  • General utility supply system, ceiling-mounted
No Description
TEKNIMED
C10A
In Commercial Distribution

  • 03760177046528 ()
C10A

  • Vertebral bone filler, non-bioabsorbable
No Description
TEKNIMED
C10A
Not in Commercial Distribution

  • 03760177041677 ()
C10A

  • Vertebral bone filler, non-bioabsorbable
The PREMIO 10 – Moxa is a medical device for heat therapy. It consists of the following: • A handpiece with a Power Supply (110-240V~ /50-60Hz) • A tip concentrator • An user manual • A cover of arrangement The PREMIO 10 - MOXA is a non-invasive infrared lamp intended to provide topical heating. The PREMIO 10 - MOXA is indicated for temporary relief of minor muscle and joint pain, arthritis and muscle spasm, relieving stiffness, promoting relaxation of muscle tissue, and to temporarily increase local blood circulation where heat is indicated.
SEDATELEC
PREMIO 10
Not in Commercial Distribution

  • 03760262493107 ()
111237

  • Musculoskeletal infrared phototherapy unit, non-wearable
No Description
SEBIA
4540
In Commercial Distribution

  • 03607360045404 ()
4540

  • Citrate staining/testing reagent IVD
Urine Reagent Strips (URS) for Urinalysis are firm plastic strips to which several different reagent areas are affixed
Immunostics Company, Inc
IDU-10
In Commercial Distribution

  • 20722355002204 ()
  • 10722355002221 ()
  • 80722355002220 ()


  • Multiple urine analyte IVD, kit, rapid colorimetric, clinical
PERFECTEMP10 50mL CART BL-2
DEN-MAT HOLDINGS, LLC
SPD1309
In Commercial Distribution

  • D813SPD13090 ()
SPD1309

  • Dental composite resin
PERFECTEMP10 50mL CART B1
DEN-MAT HOLDINGS, LLC
SPD1308
In Commercial Distribution

  • D813SPD13080 ()
SPD1308

  • Dental composite resin
PERFECTEMP10 50mL CART A3.5
DEN-MAT HOLDINGS, LLC
SPD1307
In Commercial Distribution

  • D813SPD13070 ()
SPD1307

  • Dental composite resin
PERFECTEMP10 50mL CART A2
DEN-MAT HOLDINGS, LLC
SPD1306
In Commercial Distribution

  • D813SPD13060 ()
SPD1306

  • Dental composite resin
PERFECTEMP10 50mL CART A1
DEN-MAT HOLDINGS, LLC
SPD1305
In Commercial Distribution

  • D813SPD13050 ()
SPD1305

  • Dental composite resin
PERFECTEMP10 10mL SYR A2
DEN-MAT HOLDINGS, LLC
CR1220
In Commercial Distribution

  • D813CR12200 ()
CR1220

  • Dental composite resin
PERFECTEMP10 10mL SYR A3.5
DEN-MAT HOLDINGS, LLC
CR1219
In Commercial Distribution

  • D813CR12190 ()
CR1219

  • Dental composite resin
PERFECTEMP10 10mL SYR A1
DEN-MAT HOLDINGS, LLC
CR1218
In Commercial Distribution

  • D813CR12180 ()
CR1218

  • Dental composite resin
Oxygen Concentrator, 1-10 LPM, Dual flow with standard 1-10 LPM flow meters, Oxygen Monitor options, Re-manufactured.
AIRSEP CORPORATION
AS099-4U
In Commercial Distribution

  • M638AS0994U0 ()


  • Stationary oxygen concentrator
Oxygen Concentrator, 1-10 LPM, Dual flow with standard 1-10 LPM flow meters, Oxygen Monitor options.
AIRSEP CORPORATION
AS099-4
In Commercial Distribution

  • M638AS09940 ()


  • Stationary oxygen concentrator
Oxygen Concentrator, 1-10 LPM, Dual flow option with standard 1-10 LPM flow meters.
AIRSEP CORPORATION
AS099-1U
In Commercial Distribution

  • M638AS0991U0 ()


  • Stationary oxygen concentrator
Oxygen Concentrator, 1-10 LPM, Single flow, with Oxygen Monitor, Re-manufactured.
AIRSEP CORPORATION
AS099-101U
In Commercial Distribution

  • M638AS099101U0 ()


  • Stationary oxygen concentrator
Oxygen Concentrator, 1-10 LPM Single Flow Meter with Oxygen Monitor option
AIRSEP CORPORATION
AS099-101
In Commercial Distribution

  • M638AS0991010 ()


  • Stationary oxygen concentrator
Oxygen Concentrator, 1-10 LPM, Single flow, Re-manufactured.
AIRSEP CORPORATION
AS099-100U
In Commercial Distribution

  • M638AS099100U0 ()


  • Stationary oxygen concentrator
Oxygen Concentrator, 1-10 LPM Single Flow Meter, base model
AIRSEP CORPORATION
AS099-100
In Commercial Distribution

  • M638AS0991000 ()


  • Stationary oxygen concentrator
Oxygen Concentrator, 1-10 LPM, Dual flow option, Standard 1-10 LPM flow meters.
AIRSEP CORPORATION
AS099-1
In Commercial Distribution

  • M638AS09910 ()


  • Stationary oxygen concentrator
Guidewire
BOSTON SCIENTIFIC CORPORATION
H749393043000
In Commercial Distribution

  • 08714729886648 ()
  • 08714729887706 ()

  • 0.014 in Diameter
  • 300 cm Effective Length


  • Cardiac/peripheral vascular guidewire, single-use
Guidewire
BOSTON SCIENTIFIC CORPORATION
H749393041900
In Commercial Distribution

  • 08714729886631 ()
  • 08714729887690 ()

  • 0.014 in Diameter
  • 190 cm Effective Length


  • Cardiac/peripheral vascular guidewire, single-use
Drill Guide
NOVASTEP
XDG01001
In Commercial Distribution

  • 03700879500485 ()
XDG01001

  • General internal orthopaedic fixation system implantation kit
Forceps
NOVASTEP
XFP03001
In Commercial Distribution

  • 03700879500614 ()
XFP03001

  • General internal orthopaedic fixation system implantation kit
Wheelchair cushion
Vicair B.V.
OVR10/SPECIAL SIZE
In Commercial Distribution

  • 08717261043715 ()


  • Wheelchair seat cushion
Wheelchair cushion
Vicair B.V.
OAD10/SPECIAL SIZE
In Commercial Distribution

  • 08717261040882 ()


  • Wheelchair seat cushion
HyProCure Sinus Tarsi Implant Size 10. Indications: HyProCure is a talotarsal stabilization device used in the treatment of talotarsal dislocation and resulting sequela. The implant is designed to stabilize the talus on the tarsal mechanism to prevent excessive anterior, and/or medial, and/or plantarflexion of the talus on the tarsal mechanism, while allowing normal talotarsal joint motion.
Gramedica
HYP-10
In Commercial Distribution

  • M621HYP100 ()

  • 10mm
HYP-10

  • Subtalar implant, non-bioabsorbable
HyProCure Sizer 10. Reusable instrument, for use with the HyProCure Sinus Tarsi Implant System. Indications: HyProCure is a talotarsal stabilization device used in the treatment of talotarsal dislocation and resulting sequela. The implant is designed to stabilize the talus on the tarsal mechanism to prevent excessive anterior, and/or medial, and/or plantarflexion of the talus on the tarsal mechanism, while allowing normal talotarsal joint motion.
Gramedica
CP15-10-FG
In Commercial Distribution

  • M621CP1510FG0 ()
CP15-10-FG

  • Orthopaedic prosthesis implantation positioning instrument, reusable
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