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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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No Description
Double Medical Technology Inc.
110355300
In Commercial Distribution

  • 06902139111906 ()
110355300

  • Fluted surgical drill bit, reusable
No Description
Double Medical Technology Inc.
110071300
In Commercial Distribution

  • 06902139110916 ()
110071300

  • Surgical drill guide, reusable
Operating table accessory
Merivaara Oy
STIRRUP CLAMP WITH ROTATION 19114
In Commercial Distribution

  • 06438435191149 ()
100019114

  • Operating table orthopaedic extension, non-powered
No Description
Double Medical Technology Inc.
110304100
In Commercial Distribution

  • 06902139111814 ()
110304100

  • Surgical screwdriver, reusable
Operating table accessory
Merivaara Oy
LEG REST WITH PADDING 19120
In Commercial Distribution

  • 06438435191200 ()
100019120

  • Operating table orthopaedic extension, non-powered
No Description
WESTMED, INC.
9440
In Commercial Distribution

  • 10709078004794 ()
  • 00709078004797 ()


  • Oxygen administration tubing
The SuperTrapeze is a high quality, commercial grade over-bed trapeze that connects to the SuperPole (floor to ceiling safety pole). The SuperTrapeze handle features two offset ladder rungs to allow for improved use of arm strength and increased comfort. Additionally, it can hook around the pole to store out of the way when not in use. The SuperTrapeze handle is intended for moderate vertical load bearing to provide sitting and standing support for people with reduced mobility. The SuperTrapeze handle is installed onto the SuperPole by securing a support arm to the pole with 3 cone point set screws. The set screws pierce into the pole and lock the support arm in place, and the spring ring is used to prevent the set screws from back-threading. The support arm has an adjustable strap that attaches to the trapeze handle. The SuperTrapeze handle is strong enough to support the user when sitting up in bed and standing. It is important to set proper height and orientation of the SuperTrapeze to optimize the user’s range of motion. The maximum user weight for this product is 300lbs / 136kgs. Note: Product is not intended to support full body weight.
Healthcraft Products Inc.
STP-S
In Commercial Distribution

  • 00689281020596 ()
02059

  • Hand rail
No Description
SOMNOmedics AG
NGDV741U
In Commercial Distribution

  • 04250413410699 ()


  • Polysomnograph
Lower face cuff with link
Hilotherm GmbH
Cuff - single patient use
In Commercial Distribution

  • 04250387100541 ()
15000012

  • Circulating-fluid localized thermal therapy system pack, single-use
No Description
Noras MRI products GmbH
01
In Commercial Distribution

  • 04251269204715 ()
113382

  • MRI system coil, radio-frequency
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