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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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CANES - CAROLINA BLUE, 5K BULK LOOSE, 5000 devices per package, see www.auradonics.com
AURADONICS INC.
300-427 BK
In Commercial Distribution

  • 00810033831669 ()


  • Orthodontic archwire/bracket ligature
CANES - CAROLINA BLUE, LOADED on CANES, 1000 devices per package, see www.auradonics.com
AURADONICS INC.
300-427
In Commercial Distribution

  • 00810033831652 ()


  • Orthodontic archwire/bracket ligature
DreamStation Cellular Modem with Oximetry, South Korea
Respironics, Inc.
01
In Commercial Distribution

  • 00606959058170 ()
100770W

  • Clinical laboratory information system
DreamStation Auto BiPAP System, South African Version
Respironics, Inc.
DreamStation Auto BiPAP, ZA
In Commercial Distribution

  • 00606959028029 ()
ZAX700S15

  • Home BPAP unit
STRL ACL ACCESS T R V SOUTH
Cardinal Health 200, LLC
SOP33ATGHF
In Commercial Distribution

  • 50887488489467 ()
  • 10887488489469 ()
SOP33ATGHF

  • Orthopaedic surgical procedure kit, non-medicated, single-use
Personal Use Kit OC-Auto, for Kaiser South
POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC
OCPU-KPS
In Commercial Distribution

  • 00816917024974 ()


  • Faecal occult blood IVD, reagent
Pack Percutaneous F/ South Texas Surgical Institute
HENRY SCHEIN, INC.
5703218
In Commercial Distribution

  • H65857032181 ()
  • H65857032185 ()
5703218

  • General surgical procedure kit, non-medicated, single-use
Precision Flow Heliox 4th Ed, South Africa
VAPOTHERM, INC.
PFH-UKIT-ZA
In Commercial Distribution

  • 00841737105015 ()


  • Respiratory oxygen sensor
  • Electrical mains power cable
MTS LEFT HEART KIT SOUTH CENTRAL REG
MEDLINE INDUSTRIES, INC.
60194771
In Commercial Distribution

  • 20193489051206 ()
  • 10193489051209 ()
60194771

  • Angiography kit
KIT, TRAUMA LIFE SAVER - COY - 3 SOUTH
NORTH AMERICAN RESCUE, LLC
85-1615
In Commercial Distribution

  • 00842209104956 ()
85-1615

  • First aid kit, non-medicated, single-use
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