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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 Class Implantable

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CRW® - 10381780251934

CRW-PBS HARDWARE KIT
INTEGRA LIFESCIENCES CORPORATION
CRWPBSHK
In Commercial Distribution

  • M433CRWPBSHK1 ()
  • 10381780251934 ()


  • Stereotactic radiosurgical invasive head frame

GALILEOS - E27664488770

GALILEOS Hardware Comfort PLUS
SIRONA Dental Systems GmbH
6448877
Not in Commercial Distribution

  • E27664488770 ()


  • Stationary panoramic/tomographic dental x-ray system, digital

GALILEOS - E27662999990

GALILEOS Hardware Comfort PLUS
SIRONA Dental Systems GmbH
6299999
Not in Commercial Distribution

  • E27662999990 ()


  • Stationary panoramic/tomographic dental x-ray system, digital

OmnisEMG - B179OMNI13E87E4

Biomechanical function analysis / interactive rehabilitation system
ACCELERATED CARE PLUS CORP
44144
In Commercial Distribution

  • B179OMNI13E87E4 ()


  • Biomechanical function analysis/interactive rehabilitation system

CRW® - 10381780251927

CRW® Replacement Hardware Kit
INTEGRA LIFESCIENCES CORPORATION
CRWHK
Not in Commercial Distribution

  • M248CRWHK1 ()
  • 10381780251927 ()


  • Stereotactic radiosurgical invasive head frame

Integra® - 10381780252443

Integra® Hardware Kit for UCHR
INTEGRA LIFESCIENCES CORPORATION
UCHRHK
In Commercial Distribution

  • M248UCHRHK1 ()
  • 10381780252443 ()
UCHRHK

  • Stereotactic radiosurgical invasive head frame

Premier Heart MCG Model VH12 - B320VH120

Premier Heart MCG 12 Lead capture hardware.
PREMIER HEART, LLC
VH12
In Commercial Distribution

  • B320VH120 ()


  • Electrocardiograph, professional, multichannel

Everest & Jennings - M368907632C1A1

CROSSBRACE 16W - ADJUSTABLE DEPTH & CBOLT-PR (INCLUDES 4 LINKAGES,2 SADDLE BUSHINGS, 2 CRADDLE AND HARDWARE, 2 GASKETS & HARDWARE)
GF HEALTH PRODUCTS, INC.
907632C1A
In Commercial Distribution

  • M368907632C1A1 ()
907632C1A

  • Wheelchair, attendant/occupant-driven, rear-wheels-operated, collapsible

Everest & Jennings - M36890763003A1

INNER BOTTOM RAIL WITH HARDWARE - PR - TRAVELER SE
GF HEALTH PRODUCTS, INC.
90763003A
In Commercial Distribution

  • M36890763003A1 ()
90763003A

  • Push-rim manual wheelchair, non-bariatric

Waya Rehab - G741WHREHABV10

Waya® Rehab is a software only medical device to support rehabilitation under the guidance of a qualified healthcare professional.
WELLOVATE, LLC
1
In Commercial Distribution

  • G741WHREHABV10 ()


  • Biomechanical function analysis/interactive rehabilitation system
  • Biomechanical function analysis/rehabilitation software
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