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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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Clear TPE Beaded Balloon 5 pack
H & A Mui Enterprises Inc
CBS6TB(5)
In Commercial Distribution

  • 00678467005533 ()


  • Gastrointestinal motility manometric catheter, non-electronic
Calcium compound bone void filler (5 cc)
Vivorte, Inc
5 cc
In Commercial Distribution

  • 00868201000171 ()
131133-05-S

  • Bone matrix implant, synthetic, non-antimicrobial
Calcium compound bone void filler (5 cc)
Vivorte, Inc
5 cc
Not in Commercial Distribution

  • 00868201000140 ()


  • Bone matrix implant, synthetic, non-antimicrobial
Calcium compound bone void filler (5 cc)
Vivorte, Inc
5 cc
Not in Commercial Distribution

  • 00868201000119 ()
131133-05

  • Bone matrix implant, synthetic, non-antimicrobial
MR-RT is an add-on to the existing Ingenia 1.5T and 3.0T MR systems that makes the system suitable for MR imaging for radiation therapy planning purposes. MR-RT consists of RTGo SW and MR CouchTop accessory. RTgo is a software that provides MR-RT functionality including MRCAT (MRCAT Prostate, MRCAT Pelvis, MRCAT Brain, MRCAT Head &Neck)
Philips Medical Systems Nederland B.V.
RTgo 5
In Commercial Distribution

  • 00884838122123 ()
781439

  • MRI system application software
Ultrasonic dental scaling/debridement system
Guilin Woodpecker Medical Instrument Co., Ltd.
PT 5
In Commercial Distribution

  • 06944843610047 ()


  • Ultrasonic dental scaling/debridement system
HIGH PULL HEADCAP SMALL
G & H Wire Company, Inc.
HPS**5
In Commercial Distribution

  • 10190886000274 ()
  • 00190886000277 ()


  • Orthodontic extraoral headgear
LARGE
G & H Wire Company, Inc.
HPL**5
In Commercial Distribution

  • 10190886000250 ()
  • 00190886000253 ()


  • Orthodontic extraoral headgear
Anti-scatter X-ray Grid used as part of Digital X-ray Imaging System that is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications.
Samsung Electronics Co., Ltd.
Grid 5
In Commercial Distribution

  • 08806088508931 ()


  • Stationary x-ray grid
No Description
ZIMMER DENTAL INC.
DHT4/5
In Commercial Distribution

  • 00889024014619 ()

  • Device Size Text, specify:


  • Dental implant suprastructure, temporary, preformed, single-use
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