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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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Megadyne - 10614559104347

Bipolar Forcep Reusable Adson 1.0 mm tip 4 in (10.2 cm)
MEGADYNE MEDICAL PRODUCTS, INC.
4040
Not in Commercial Distribution

  • 10614559104347 ()


  • Electrosurgical system generator

Megadyne - 10614559103807

E-Z Clean, Non-stick, PTFE Coated, Precision Blade Electrode, 2.75 in (7cm)
MEGADYNE MEDICAL PRODUCTS, INC.
0012AP
Not in Commercial Distribution

  • 30614559103801 ()
  • 10614559103807 ()


  • Open-surgery electrosurgical electrode, monopolar, single-use

EdgeTip™ #6 - 00818365020195

Short Titanium-Niobium tip for retreatment in the crown third and isthmuses
EDGE ENDO LLC
ET25S
In Commercial Distribution

  • 00818365020195 ()


  • Ultrasonic dental scaling/debridement system handpiece tip, endodontic

Isolation Transformer 100-120V - 07640121880902

Isolates the SDM from mains for use in home use environments.
SenTec AG
RFT100VA-V1
In Commercial Distribution

  • 07640121880902 ()


  • Pulse Co-oximeter probe, reusable
  • Transcutaneous blood gas monitor sensor
  • Transcutaneous blood gas monitoring system

Buffalo Filter - 00815198011284

Smoke Evacuation Tubing with 8 in integral wand and sponge guard
Buffalo Filter
VTWT206
Not in Commercial Distribution

  • 10815198011281 ()
  • 00815198011284 ()

  • Length: 6 Feet
  • Lumen/Inner Diameter: 1.250 Inch


  • Surgical plume evacuation system tube

Buffalo Filter - 00815198011055

Smoke Evacuation Tubing with 8 in integral wand and sponge guard
Buffalo Filter
VTWT406
Not in Commercial Distribution

  • 10815198011052 ()
  • 00815198011055 ()

  • Lumen/Inner Diameter: 1.250 Inch
  • Length: 10 Feet


  • Surgical plume evacuation system tube

DUPLOTIP - 00815634020146

APPLICATOR TIP DUAL CANNULA 5 MM X 31.8 CM (12.5 IN)
Micromedics, Inc.
SA376003000000
In Commercial Distribution

  • 00815634020146 ()
  • 10815634020143 ()


  • Open-surgery adhesive/sealant applicator, dual-channel

DUPLOTIP - 00815634020139

APPLICATOR TIP DUAL CANNULA 20 GA X 26.4 CM (10.5 IN)
Micromedics, Inc.
SA375003000000
In Commercial Distribution

  • 00815634020139 ()
  • 10815634020136 ()


  • Open-surgery adhesive/sealant applicator, dual-channel

Curaplex - 00815277023290

Curaplex Suction Tubing 1/4 in x 6 ft 20ea/pk
BOUND TREE MEDICAL, LLC
16106
In Commercial Distribution

  • 00815277023306 ()
  • 00815277023290 ()
16106

  • Surgical/emergency suction cannula, non-illuminating, single-use

Curaplex - 00815277021982

Curaplex Mass Spec in a Sealed Plastic Bag Latex Free Kit
BOUND TREE MEDICAL, LLC
681250
In Commercial Distribution

  • 00815277021982 ()


  • First aid kit, non-medicated, reusable
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