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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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Respire Pink+ Hard with DentiTrac - 00851861007222

Intraoral appliance for the treatment of snoring and mild to moderate obstructive sleep apnea with patient monitoring.
RESPIRE MEDICAL HOLDINGS LLC
SPPD000US
Not in Commercial Distribution

  • 00851861007222 ()

  • Circumference: 200 Millimeter


  • Mandible-repositioning sleep-disordered breathing orthosis

Traction bar with ball joint - 04046768134072

No Description
MAQUET GmbH
100740A0
In Commercial Distribution

  • 04046768134072 ()


  • Operating table orthopaedic extension, non-powered

Adapter clamp with transfer board - 04046768040960

No Description
MAQUET GmbH
118051A0
In Commercial Distribution

  • 04046768040960 ()


  • Leg procedure positioner

Arm board with SFC padding - 04046768028784

No Description
MAQUET GmbH
100243C0
In Commercial Distribution

  • 04046768028784 ()


  • Arm procedure positioner, reusable

Sitting bracket with pelvis support - 04046768002159

No Description
MAQUET GmbH
100705A0
In Commercial Distribution

  • 04046768002159 ()


  • Spinal surgery positioning board

dermaPACE System (Console with applicator) - 00812265010225

The dermaPACE console and applicator shipped together. An assembly of devices designed to provide high-energy, spark-gap generated (electrohydraulic) extracorporeal shock wave intended to treat diabetic foot ulers.
Sanuwave, Inc.
DEP0330/DAP0332
In Commercial Distribution

  • 00812265010225 ()


  • Dermatological extracorporeal shock wave therapy system

BodyGuard® Microset with Filter - B101A120160XSFK0

110 in. (280 cm) Microset with Filter - Blue Stripe, For Use with the BodyGuard® Infusion Pump
CME AMERICA LLC
A120-160XSFK
Not in Commercial Distribution

  • B101A120160XSFK1 ()
  • B101A120160XSFK0 ()


  • Electric infusion pump administration set, single-use

BodyGuard® Microset with Filter - B101A120160XSFE0

134 in. (340 cm) Microset with Filter - Blue Stripe, For Use with the BodyGuard® Infusion Pump
CME AMERICA LLC
A120-160XSFE
Not in Commercial Distribution

  • B101A120160XSFE1 ()
  • B101A120160XSFE0 ()


  • Electric infusion pump administration set, single-use

BodyGuard® Microset with Filter - B101A120112XSFK0

110 in. (280 cm) - blue stripe, For Use with the BodyGuard® Infusion Pump
CME AMERICA LLC
A120-112XSFK
Not in Commercial Distribution

  • B101A120112XSFK1 ()
  • B101A120112XSFK0 ()


  • Electric infusion pump administration set, single-use

BodyGuard® Microset with Filter - B101A100164XESF0

105 in. (270 cm) - yellow stripe, For Use with the BodyGuard® Infusion Pump
CME AMERICA LLC
A100-164XESF
Not in Commercial Distribution

  • B101A100164XESF0 ()
  • B101A100164XESF1 ()


  • Electric infusion pump administration set, single-use
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