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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 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
*Custom* South Metro Small Volume Neb Kit
BOUND TREE MEDICAL, LLC
8600-01359
In Commercial Distribution

  • 00812277033427 ()
8600-01359

  • Nebulizing system delivery set, single-use
*Custom* South Metro 22ga Hypo Needle Kit
BOUND TREE MEDICAL, LLC
8600-01358
In Commercial Distribution

  • 00812277033410 ()
8600-01358

  • Blood transfusion set, non-exchange
*CUSTOM* South Metro Introcan IV Catheter 24ga
BOUND TREE MEDICAL, LLC
8600-01353
In Commercial Distribution

  • 00812277033052 ()
8600-01353

  • Peripheral vascular intervention infusion catheter
*CUSTOM* South Metro Introcan IV Catheter 22ga
BOUND TREE MEDICAL, LLC
8600-01352
In Commercial Distribution

  • 00812277033045 ()
8600-01352

  • Peripheral vascular intervention infusion catheter
*CUSTOM* South Metro Introcan IV Catheter 20ga
BOUND TREE MEDICAL, LLC
8600-01351
In Commercial Distribution

  • 00812277033038 ()
8600-01351

  • Peripheral vascular intervention infusion catheter
*CUSTOM* South Metro Introcan IV Catheter 18ga
BOUND TREE MEDICAL, LLC
8600-01350
In Commercial Distribution

  • 00812277033021 ()
8600-01350

  • Peripheral vascular intervention infusion catheter
*CUSTOM* South Metro Introcan IV Catheter 16ga
BOUND TREE MEDICAL, LLC
8600-01349
In Commercial Distribution

  • 00812277033014 ()
8600-01349

  • Peripheral vascular intervention infusion catheter
*CUSTOM* South Metro Introcan IV Catheter 14ga
BOUND TREE MEDICAL, LLC
8600-01348
In Commercial Distribution

  • 00812277033007 ()
8600-01348

  • Peripheral vascular intervention infusion catheter
CUSTOM PACK BB11W58R1 BAP SOUTH E C
MEDTRONIC, INC.
BB11W58R1
In Commercial Distribution

  • 00763000652906 ()


  • Cardiopulmonary bypass system blood tubing set
CUSTOM PACK BB11W58R3 BAP SOUTH E C
MEDTRONIC, INC.
BB11W58R3
In Commercial Distribution

  • 00763000963705 ()


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

  • M397PS103130ZA0 ()
PS10-3130-ZA

  • Plasma surgical system
PlasmaJet V3 Plus Console System (South Africa)
PLASMA SURGICAL, INC
PS10-2130-ZA
In Commercial Distribution

  • M397PS102130ZA0 ()
PS10-2130-ZA

  • Plasma surgical system
MESURING PROBE PERIODONTIC, BIONIK HANDLE LIGHTRED-MAGENTA PA PROBE CAROLINA CNC, PROBE FIG 16
Helmut Zepf Medizintechnik GmbH
24.853.24
In Commercial Distribution

  • EZPF24853240 ()
24.853.24

  • Dental surgical probe, reusable
MESURING PROBE PERIODONTIC, BIONIK HANDLE COBALT-BLUE PA PROBE CAROLINA CNC, PROBE FIG 16
Helmut Zepf Medizintechnik GmbH
24.853.14
In Commercial Distribution

  • EZPF24853140 ()
24.853.14

  • Dental surgical probe, reusable
MEASURING PROBE PERIODONTIC, NORTH CAROLINA, CNC, 1-15MM, TITANIUM IN BIONIK HANDLE, SINGLE-ENDED, M2,5
Helmut Zepf Medizintechnik GmbH
24.216.06
In Commercial Distribution

  • EZPF24216060 ()
24.216.06

  • Periodontal curette
Periodontal Probe # CP15 "N. Carolina" graduated; 1-2...-14-15 mm F-LINE | SL | single ended
devemed GmbH
2525-40 F
In Commercial Distribution

  • 04061644021840 ()


  • Periodontal probe, reusable
Periodontal Probe # CP15 "N. Carolina" graduated; 1-2...-14-15 mm COMFORT | SL | single ended
devemed GmbH
02-2525-40 C
In Commercial Distribution

  • 04061644035090 ()


  • Periodontal probe, reusable
Kit Contains: CD001, 10mm RETRIEVAL SYSTEM, 10/BX CA500, EPIX® UNIVERSAL CLIP APPLIER 3/BX CFS02, 5x100 Kii® SLEEVE ADVFIX 12/BX CFF03, 5x100 Kii® Fios® ADVFIX 6/BX CFF73, 12x100 Kii® Fios® ADVFIX 6/BX
APPLIED MEDICAL RESOURCES CORPORATION
K2749
In Commercial Distribution

  • 30607915134212 ()


  • Tissue extraction bag
  • Laparoscopic access cannula, single-use
  • Ligation clip, metallic
EVERFLO w/Oxygen Percentage Indicator, 230V, South Africa
Respironics, Inc.
EVERFLO w/Oxygen Percentage Indicator, 230V, ZA
In Commercial Distribution

  • 00606959032583 ()
1020009

  • Stationary oxygen concentrator
MEDIUM TIP WITH 90° BEND SOUTH, POLISHED FINISH
PMT CORPORATION
3201-09M-09-97-PF
In Commercial Distribution

  • 00650551142355 ()

  • Length: 9 Inch
  • Catheter Gauge: 9 French
3201-09M-09-97-PF

  • Surgical irrigation/aspiration handpiece, reusable
MEDIUM TIP WITH 90° BEND SOUTH, POLISHED FINISH
PMT CORPORATION
3201-07M-09-97-PF
In Commercial Distribution

  • 00650551142331 ()

  • Length: 9 Inch
  • Catheter Gauge: 7 French
3201-07M-09-97-PF

  • Surgical irrigation/aspiration handpiece, reusable
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