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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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DISPOSABLE ULTRAPOINT MONOPOLAR NEEDLE ELECTRODES: 26 GA., 50 MM NEEDLE, 2 FT. (0.6 M) SINGLE GREEN LEADWIRE
ROCHESTER ELECTRO-MEDICAL, INC.
016395
Not in Commercial Distribution

  • 10816843022591 ()
  • 10816843022584 ()


  • Electromyographic needle electrode, single-use
DISPOSABLE ULTRAPOINT MONOPOLAR NEEDLE ELECTRODES: 26 GA., 37 MM NEEDLE, 2 FT. (0.6 M) SINGLE GREEN LEADWIRE
ROCHESTER ELECTRO-MEDICAL, INC.
016393
Not in Commercial Distribution

  • 10816843022577 ()
  • 10816843022560 ()


  • Electromyographic needle electrode, single-use
DISPOSABLE ULTRAPOINT MONOPOLAR NEEDLE ELECTRODES: 27 GA., 50 MM NEEDLE, 2 FT. (0.6 M) SINGLE BLUE LEADWIRE
ROCHESTER ELECTRO-MEDICAL, INC.
016391
Not in Commercial Distribution

  • 10816843022553 ()
  • 10816843022546 ()


  • Electromyographic needle electrode, single-use
DISPOSABLE ULTRAPOINT MONOPOLAR NEEDLE ELECTRODES: 27 GA., 37 MM NEEDLE, 2 FT. (0.6 M) SINGLE BLUE LEADWIRE
ROCHESTER ELECTRO-MEDICAL, INC.
016388
Not in Commercial Distribution

  • 10816843022539 ()
  • 10816843022522 ()


  • Electromyographic needle electrode, single-use
DISPOSABLE ULTRAPOINT MONOPOLAR NEEDLE ELECTRODES: 27 GA., 25 MM NEEDLE, 2 FT. (0.6 M) SINGLE BLUE LEADWIRE
ROCHESTER ELECTRO-MEDICAL, INC.
016386
Not in Commercial Distribution

  • 10816843022515 ()
  • 10816843022508 ()


  • Electromyographic needle electrode, single-use
DISPOSABLE ULTRAPOINT MONOPOLAR NEEDLE ELECTRODES: 28 GA., 45 MM NEEDLE, 2 FT. (0.6 M) SINGLE ORANGE LEADWIRE
ROCHESTER ELECTRO-MEDICAL, INC.
016384
Not in Commercial Distribution

  • 10816843022492 ()
  • 10816843022485 ()


  • Electromyographic needle electrode, single-use
DISPOSABLE ULTRAPOINT MONOPOLAR NEEDLE ELECTRODES: 28 GA., 37 MM NEEDLE, 2 FT. (0.6 M) SINGLE ORANGE LEADWIRE
ROCHESTER ELECTRO-MEDICAL, INC.
016383
Not in Commercial Distribution

  • 10816843022478 ()
  • 10816843022461 ()


  • Electromyographic needle electrode, single-use
DISPOSABLE ULTRAPOINT MONOPOLAR NEEDLE ELECTRODES: 29 GA., 37 MM NEEDLE, 2 FT. (0.6 M) SINGLE RED LEADWIRE
ROCHESTER ELECTRO-MEDICAL, INC.
016380
Not in Commercial Distribution

  • 10816843022454 ()
  • 10816843022447 ()


  • Electromyographic needle electrode, single-use
REUSABLE FIXED BAR ELECTRODES: 9 MM TIN DISC, 3 CM BETWEEN DISCS, 4 FT. (1.2M), TWISTED WIRE
ROCHESTER ELECTRO-MEDICAL, INC.
032543
Not in Commercial Distribution

  • 10816843020023 ()


  • Analytical non-scalp cutaneous lead
Curaplex Oxygen Mask, Adult, Elongated, Total NRB w/o Vent, Reservoir Bag, 7 ft Tubing 50ea/cs
BOUND TREE MEDICAL, LLC
30052
In Commercial Distribution

  • 00812277038798 ()
  • 00812277037531 ()
30052

  • Non-rebreathing oxygen face mask
6 ft. long x 1.3" diameter hose with connector for use with TX Pack or LTX Pack
ACUDERM, INC.
HOSE
In Commercial Distribution

  • 00814105020517 ()


  • Surgical plume evacuation system
ZIP Pen Ergonomic Smoke Evacuation Pencil E-Z Clean, Non-Stick, PTFE Coated, 10 Ft (3.04m) Tubing, 22mm Connector
MEGADYNE MEDICAL PRODUCTS, INC.
252510EC
In Commercial Distribution

  • 10614559105344 ()
  • 30614559105348 ()
252510EC

  • Surgical plume evacuation system
ZIP Pen Ergonomic Smoke Evacuation Pencil E-Z Clean, Non-Stick, PTFE Coated, 10 Ft (3.04m) Tubing, 22mm Connector
MEGADYNE MEDICAL PRODUCTS, INC.
2525-10EC
Not in Commercial Distribution

  • 30614559104327 ()
  • 10614559104323 ()


  • Electrosurgical system generator
Electrosurgical Pencil Button Switch Non Coated Blade Electrode 10 ft (3 m) cord Holster Bulk Non Sterile
MEGADYNE MEDICAL PRODUCTS, INC.
0039HBN
Not in Commercial Distribution

  • 30614559101388 ()
  • 10614559101384 ()


  • Open-surgery electrosurgical handpiece/electrode, monopolar, single-use
Electrosurgical Pencil Rocker Switch Non Coated Blade Electrode 10 ft (3 m) cord Holster Bulk Non Sterile
MEGADYNE MEDICAL PRODUCTS, INC.
0038HBN
Not in Commercial Distribution

  • 30614559101364 ()
  • 10614559101360 ()


  • Open-surgery electrosurgical handpiece/electrode, monopolar, single-use
Electrosurgical Pencil Button Switch E-Z Clean Coated Blade Electrode 10 ft (3 m) cord Bulk Non Sterile
MEGADYNE MEDICAL PRODUCTS, INC.
0035BN
Not in Commercial Distribution

  • 30614559101333 ()
  • 10614559101339 ()


  • Open-surgery electrosurgical handpiece/electrode, monopolar, single-use
Electrosurgical Pencil Rocker Switch E-Z Clean Coated Blade Electrode 10 ft (3 m) cord Bulk Non Sterile
MEGADYNE MEDICAL PRODUCTS, INC.
0030BN
Not in Commercial Distribution

  • 30614559101319 ()
  • 10614559101315 ()


  • Open-surgery electrosurgical handpiece/electrode, monopolar, single-use
Warming Cabinet Single Compartment Counter-Top Model (Glass Door) / 29" x 26" x 34", 7.2 CU. FT/PI3
Imperial Surgical Ltd
OR-8154
In Commercial Distribution

  • 07540162040092 ()
OR-8154

  • Multi-purpose warming cabinet, stationary
Warming Cabinet Single Compartment Counter-Top Model (SS Door) /29" x 26" x 34", 7.2 CU. FT/PI3
Imperial Surgical Ltd
OR-7154
In Commercial Distribution

  • 07540162040085 ()
OR-7154

  • Multi-purpose warming cabinet, stationary
Warming Cabinet Single Compartment Counter-Top Model (Glass Door)/ 29" x 20" x 34", 5.2 CU. FT/PI3
Imperial Surgical Ltd
OR-8054
In Commercial Distribution

  • 07540162040078 ()
OR-8054

  • Multi-purpose warming cabinet, stationary
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