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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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IPPS™ Overlay - 00841439106839

53cm overlay with template for use with Philips Ingenia
MEDTEC, INC.
MTM3406
In Commercial Distribution

  • 00841439106839 ()
MTM3406

  • Indexed-immobilization patient positioning system

Universal Couchtop™ - 00841439105719

For use with Elekta X-Box base with Lok-Bar™
MEDTEC, INC.
MTIL624015
In Commercial Distribution

  • 00841439105719 ()
MTIL624015

  • Indexed-immobilization patient positioning system

Universal Couchtop™ - 00841439105467

For use with Siemens Definition MPT with Lok-Bar™
MEDTEC, INC.
MTIL604515
In Commercial Distribution

  • 00841439105467 ()
MTIL604515

  • Indexed-immobilization patient positioning system

NA - 10886982187956

3.5MM/2.7MM DRILL GUIDE WITH STOP, WITH TWO INSERTS
Synthes GmbH
312.85
In Commercial Distribution

  • H679312850 ()
  • 10886982187956 ()
31285

  • Surgical drill guide, reusable

RZ Medizintechnik GmbH - 04049197312226

Aural Suction Handle with Luer cone with finger cut-off
RZ-Medizintechnik GmbH
420-196-000
In Commercial Distribution

  • 04049197312226 ()
420-196-000

  • Ear canal suction handle

FITLIFE - 00606959023093

FitLife Mask with Headgear, with Standard Elbow, Large, Japan
Respironics, Inc.
FitLife Mask with Headgear, w/SE, Large, Japan
Not in Commercial Distribution

  • 00606959023093 ()
1061714

  • CPAP/BPAP face mask, reusable

FITLIFE - 00606959023055

FitLife Mask with Standard Elbow, with Headgear, Small, INTL
Respironics, Inc.
FitLife Mask with Headgear, w/SE, Small, INTL
In Commercial Distribution

  • 00606959023055 ()
1061711

  • CPAP/BPAP face mask, reusable

DreamStation - 00606959022546

DreamStation Auto BiPAP with Humidifier, with Heated Tube, USA
Respironics, Inc.
DreamStation Auto BiPAP w/Humid, w/H Tube, US
In Commercial Distribution

  • 00606959022546 ()
DSX700T11

  • Home BPAP unit

REMstar SE - 00606959020054

REMstar SE with Heated Tube, with SD Slot, AH
Respironics, Inc.
REMstar SE with Heated Tube, with SD Slot, AH
In Commercial Distribution

  • 00606959020054 ()
AH220TS

  • Heated respiratory humidifier
  • Home CPAP unit

AF531 - 00606959012295

AF531 Mask with Standard Elbow, with CapStrap, Medium, USA
Respironics, Inc.
AF531 Mask w/SE, with CapStrap, Medium, USA
In Commercial Distribution

  • 30606959012296 ()
  • 00606959012295 ()
1094806

  • CPAP/BPAP face mask, single-use
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