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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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DreamStation Auto BiPAP System, South African Version
Respironics, Inc.
DreamStation Auto BiPAP, ZA
In Commercial Distribution

  • 00606959028029 ()
ZAX700S15

  • Home BPAP unit
PlasmaJet V3 Plus Console System (South Africa)
PLASMA SURGICAL, INC
PS10-2130-ZA
In Commercial Distribution

  • M397PS102130ZA0 ()
PS10-2130-ZA

  • Plasma surgical system
PlasmaJet Ultra Plus Console System (South Africa)
PLASMA SURGICAL, INC
PS10-3130-ZA
In Commercial Distribution

  • M397PS103130ZA0 ()
PS10-3130-ZA

  • Plasma surgical system
CUSTOM PACK BB11W58R3 BAP SOUTH E C
MEDTRONIC, INC.
BB11W58R3
In Commercial Distribution

  • 00763000963705 ()


  • Cardiopulmonary bypass system blood tubing set
CUSTOM PACK BB11W58R1 BAP SOUTH E C
MEDTRONIC, INC.
BB11W58R1
In Commercial Distribution

  • 00763000652906 ()


  • Cardiopulmonary bypass system blood tubing set
STRL ACL ACCESS T R V SOUTH
Cardinal Health 200, LLC
SOP33ATGHE
In Commercial Distribution

  • 50885425725210 ()
  • 00885425725215 ()
SOP33ATGHE

  • 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
PA-PROBE, NORTH CAROLINA CNC, 1MM SINGLE ENDED HUERZELER/ZUHR DESIGN HANDLE, EXCHANGEABLE
Helmut Zepf Medizintechnik GmbH
24.744.50HZU
In Commercial Distribution

  • EZPF2474450HZU0 ()
24.744.50HZU

  • Periodontal curette
Blood Culture Collection Kit, Steripath, Line Draw, Carolina East Medical Center Only
AERO-MED, LLC
CA25400
Not in Commercial Distribution

  • 10885380178238 ()
  • 20885380178235 ()
CA25400

  • Phlebotomy kit
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
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