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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SAGITTAL BLADE - DE SOUTTER MICRO 4 x 17 x 0.51mm
DE SOUTTER MEDICAL LIMITED
S92-120
In Commercial Distribution

  • 15051471028071 ()
  • 05051471028074 ()
S92-120

  • Surgical saw blade, sagittal, single-use
BUR-OVAL CARB 4mm,LONG
DE SOUTTER MEDICAL LIMITED
R16-201
In Commercial Distribution

  • 15051471028064 ()
  • 05051471028067 ()
R16-201

  • Orthopaedic bur, single-use
WIRE PASS DRILL 1.5mm
DE SOUTTER MEDICAL LIMITED
R51-102
In Commercial Distribution

  • 15051471028040 ()
  • 05051471028043 ()
R51-102

  • Fluted surgical drill bit, single-use
SWANSON PILOT DRILL 4mm
DE SOUTTER MEDICAL LIMITED
R50-103
In Commercial Distribution

  • 15051471028026 ()
  • 05051471028029 ()
R50-103

  • Fluted surgical drill bit, single-use
SWANSON PILOT DRILL 3mm
DE SOUTTER MEDICAL LIMITED
R50-102
In Commercial Distribution

  • 15051471028002 ()
  • 05051471028005 ()
R50-102

  • Fluted surgical drill bit, single-use
SWANSON PILOT DRILL 2mm
DE SOUTTER MEDICAL LIMITED
R50-101
In Commercial Distribution

  • 15051471027982 ()
  • 05051471027985 ()
R50-101

  • Fluted surgical drill bit, single-use
BONE DRILL 3.5mm
DE SOUTTER MEDICAL LIMITED
R48-135
In Commercial Distribution

  • 15051471027968 ()
  • 05051471027961 ()
R48-135

  • Fluted surgical drill bit, single-use
BONE DRILL 3.2mm
DE SOUTTER MEDICAL LIMITED
R48-132
In Commercial Distribution

  • 15051471027944 ()
  • 05051471027947 ()
R48-132

  • Fluted surgical drill bit, single-use
BONE DRILL 2.7mm
DE SOUTTER MEDICAL LIMITED
R48-127
In Commercial Distribution

  • 15051471027920 ()
  • 05051471027923 ()
R48-127

  • Fluted surgical drill bit, single-use
BONE DRILL 2.0mm
DE SOUTTER MEDICAL LIMITED
R48-120
In Commercial Distribution

  • 15051471027906 ()
  • 05051471027909 ()
R48-120

  • Fluted surgical drill bit, single-use
BONE DRILL 1.5mm
DE SOUTTER MEDICAL LIMITED
R48-115
In Commercial Distribution

  • 15051471027883 ()
  • 05051471027886 ()
R48-115

  • Fluted surgical drill bit, single-use
BONE DRILL 1.3mm
DE SOUTTER MEDICAL LIMITED
R48-113
In Commercial Distribution

  • 15051471027869 ()
  • 05051471027862 ()
R48-113

  • Fluted surgical drill bit, single-use
BONE DRILL 1.1mm
DE SOUTTER MEDICAL LIMITED
R48-111
In Commercial Distribution

  • 15051471027845 ()
  • 05051471027848 ()
R48-111

  • Fluted surgical drill bit, single-use
BUR-ROUND CARB 5mm,EXTRA LONG
DE SOUTTER MEDICAL LIMITED
R15-309
In Commercial Distribution

  • 15051471027821 ()
  • 05051471027824 ()
R15-309

  • Orthopaedic bur, single-use
BUR-ROUND CARB 4mm,EXTRA LONG
DE SOUTTER MEDICAL LIMITED
R15-308
In Commercial Distribution

  • 15051471027807 ()
  • 05051471027800 ()
R15-308

  • Orthopaedic bur, single-use
BUR-ROUND CARB 3mm,EXTRA LONG
DE SOUTTER MEDICAL LIMITED
R15-307
In Commercial Distribution

  • 15051471027784 ()
  • 05051471027787 ()
R15-307

  • Orthopaedic bur, single-use
BUR-ROUND CARB 2mm,EXTRA LONG
DE SOUTTER MEDICAL LIMITED
R15-304
In Commercial Distribution

  • 15051471027760 ()
  • 05051471027763 ()
R15-304

  • Orthopaedic bur, single-use
LAP CHOLE
MEDLINE INDUSTRIES, INC.
DYNJ56608C
In Commercial Distribution

  • 10193489278484 ()
DYNJ56608C

  • General surgical procedure kit, non-medicated, single-use
SHOULDER SPLIT I-LF
MEDLINE INDUSTRIES, INC.
DYNJ56610B
In Commercial Distribution

  • 10193489278477 ()
DYNJ56610B

  • General surgical procedure kit, non-medicated, single-use
BUR-ROUND CARB 3mm,MEDIUM
DE SOUTTER MEDICAL LIMITED
R15-107
In Commercial Distribution

  • 15051471027340 ()
  • 05051471027343 ()
R15-107

  • Orthopaedic bur, single-use
TOTAL KNEE PACK
MEDLINE INDUSTRIES, INC.
DYNJ56611B
In Commercial Distribution

  • 10193489278453 ()
DYNJ56611B

  • General surgical procedure kit, non-medicated, single-use
BUR-ROUND CARB 2.3mm,MEDIUM
DE SOUTTER MEDICAL LIMITED
R15-105
In Commercial Distribution

  • 15051471027302 ()
  • 05051471027305 ()
R15-105

  • Orthopaedic bur, single-use
C-SECTION
MEDLINE INDUSTRIES, INC.
DYNJ900266C
In Commercial Distribution

  • 40193489278430 ()
  • 10193489278439 ()
DYNJ900266C

  • General surgical procedure kit, non-medicated, single-use
BUR-ROUND CARB 1.5mm,MEDIUM
DE SOUTTER MEDICAL LIMITED
R15-102
In Commercial Distribution

  • 15051471027265 ()
  • 05051471027268 ()
R15-102

  • Orthopaedic bur, single-use
CONTINUOUS EPIDURAL TRAY
MEDLINE INDUSTRIES, INC.
PAIN1608
In Commercial Distribution

  • 10193489278415 ()
PAIN1608

  • General surgical procedure kit, medicated
HOSE ASSY FOR D170-L
DE SOUTTER MEDICAL LIMITED
7550
In Commercial Distribution

  • 05051471027152 ()
7550

  • Pneumatic surgical power tool hose
REITER KNEE PACK
MEDLINE INDUSTRIES, INC.
DYNJ904581C
In Commercial Distribution

  • 40193489278317 ()
  • 10193489278316 ()
DYNJ904581C

  • General surgical procedure kit, non-medicated, single-use
SAGITTAL BLADE - STRYKER (2296-3-412) 5.5 x 18 x 0.38mm
DE SOUTTER MEDICAL LIMITED
S59-412
In Commercial Distribution

  • 15051471027050 ()
  • 05051471027053 ()
S59-412

  • Surgical saw blade, sagittal, single-use
HUSTED ACDF
MEDLINE INDUSTRIES, INC.
DYNJ904579D
In Commercial Distribution

  • 10193489278293 ()
DYNJ904579D

  • General surgical procedure kit, non-medicated, single-use
SAGITTAL BLADE - STRYKER (2296-3-105) 9 x 18.5 x 0.38mm
DE SOUTTER MEDICAL LIMITED
S59-105
In Commercial Distribution

  • 15051471027036 ()
  • 05051471027039 ()
S59-105

  • Surgical saw blade, sagittal, single-use
BUR-SIDECUT CARB 1mm,MEDIUM
DE SOUTTER MEDICAL LIMITED
R12-102
In Commercial Distribution

  • 15051471027005 ()
  • 05051471027008 ()
R12-102

  • Orthopaedic bur, single-use
HOSE ASSY - BAYONET MA7 0.5MTR
DE SOUTTER MEDICAL LIMITED
7530
In Commercial Distribution

  • 05051471026995 ()
7530

  • Pneumatic surgical power tool hose
ABDOLVAHAV LUMBAR LAMINECTOMY
MEDLINE INDUSTRIES, INC.
DYNJ904582D
In Commercial Distribution

  • 40193489278256 ()
  • 10193489278255 ()
DYNJ904582D

  • General surgical procedure kit, non-medicated, single-use
CONVERSION HOSE MA7 TO DRAEGER
DE SOUTTER MEDICAL LIMITED
7520
In Commercial Distribution

  • 05051471026926 ()
7520

  • Pneumatic surgical power tool hose
OPEN HEART ANESTHESIA PACK
MEDLINE INDUSTRIES, INC.
CDS983849D
In Commercial Distribution

  • 40193489278232 ()
  • 10193489278231 ()
CDS983849D

  • General surgical procedure kit, medicated
The Ultimate Auto Shield Trocar has applications in minimally invasive surgical procedures to establish a path of entry for endoscopic instruments. The trocar may be used for primary and secondary insertions.
PURPLE SURGICAL INTERNATIONAL LIMITED
PS5569ULT
In Commercial Distribution

  • 35051223024874 ()
  • 05051223024873 ()
PS5569ULT

  • Laparoscopic access cannula, single-use
OPEN HEART PACK
MEDLINE INDUSTRIES, INC.
DYNJ0751503U
In Commercial Distribution

  • 10193489278156 ()
DYNJ0751503U

  • General surgical procedure kit, non-medicated, single-use
The Ultimate Cannula has applications in minimally invasive surgical procedures, and acts as a port of entry for endoscopic instruments.
PURPLE SURGICAL INTERNATIONAL LIMITED
PS5567ULT
In Commercial Distribution

  • 55051223024526 ()
  • 35051223024522 ()
  • 05051223024521 ()

  • 5mm diameter x 100mm length
PS5567ULT

  • Laparoscopic access cannula, single-use
The Ultimate Cannula has applications in minimally invasive surgical procedures, and acts as a port of entry for endoscopic instruments.
PURPLE SURGICAL INTERNATIONAL LIMITED
PS5566ULT
In Commercial Distribution

  • 55051223024519 ()
  • 35051223024515 ()
  • 05051223024514 ()

  • 12mm diameter x 100mm length
PS5566ULT

  • Laparoscopic access cannula, single-use
The Ultimate Auto Shield Trocar has applications in minimally invasive surgical procedures to establish a path of entry for endoscopic instruments. The trocar may be used for primary and secondary insertions.
PURPLE SURGICAL INTERNATIONAL LIMITED
PS5565ULT
In Commercial Distribution

  • 55051223024380 ()
  • 35051223024386 ()
  • 05051223024385 ()

  • 5mm diameter x 100mm length
PS5565ULT

  • Laparoscopic access cannula, single-use
The Ultimate Auto Shield Trocar has applications in minimally invasive surgical procedures to establish a path of entry for endoscopic instruments. The trocar may be used for primary and secondary insertions.
PURPLE SURGICAL INTERNATIONAL LIMITED
PS5564ULT
In Commercial Distribution

  • 55051223024373 ()
  • 35051223024379 ()
  • 05051223024378 ()

  • 10mm diameter x 100mm length
PS5564ULT

  • Laparoscopic access cannula, single-use
The Ultimate Auto Shield Trocar has applications in minimally invasive surgical procedures to establish a path of entry for endoscopic instruments. The trocar may be used for primary and secondary insertions.
PURPLE SURGICAL INTERNATIONAL LIMITED
PS5563ULT
In Commercial Distribution

  • 05051223024071 ()
  • 35051223024072 ()
  • 55051223024076 ()

  • 5mm diameter x 100mm length
PS5563ULT

  • Laparoscopic access cannula, single-use
The Ultimate Auto Shield Trocar has applications in minimally invasive surgical procedures to establish a path of entry for endoscopic instruments. The trocar may be used for primary and secondary insertions.
PURPLE SURGICAL INTERNATIONAL LIMITED
PS5562ULT
In Commercial Distribution

  • 55051223024045 ()
  • 35051223024041 ()
  • 05051223024040 ()

  • 12mm diameter x 100mm length
PS5562ULT

  • Laparoscopic access cannula, single-use
The Ultimate Auto Shield Trocar has applications in minimally invasive surgical procedures to establish a path of entry for endoscopic instruments. The trocar may be used for primary and secondary insertions.
PURPLE SURGICAL INTERNATIONAL LIMITED
PS5561ULT
In Commercial Distribution

  • 55051223024021 ()
  • 35051223024027 ()
  • 05051223024026 ()

  • 12mm diameter x 100mm length
PS5561ULT

  • Laparoscopic access cannula, single-use
The Ultimate Auto Shield Trocar has applications in minimally invasive surgical procedures to establish a path of entry for endoscopic instruments. The trocar may be used for primary and secondary insertions.
PURPLE SURGICAL INTERNATIONAL LIMITED
PS5560ULT
In Commercial Distribution

  • 05051223023739 ()
  • 35051223023730 ()
  • 55051223023734 ()

  • 10mm diameter x 100mm length
PS5560ULT

  • Laparoscopic access cannula, single-use
The Ultimate Dilating Tip Trocar has applications in minimally invasive surgical procedures to establish a path of entry for endoscopic instruments. The trocar may be used for primary and secondary insertions.
PURPLE SURGICAL INTERNATIONAL LIMITED
PS5476ULT
In Commercial Distribution

  • 55051223023727 ()
  • 35051223023723 ()
  • 05051223023722 ()

  • 5mm diameter x 70mm length
PS5476ULT

  • Laparoscopic access cannula, single-use
The Ultimate Dilating Tip Trocar has applications in minimally invasive surgical procedures to establish a path of entry for endoscopic instruments. The trocar may be used for primary and secondary insertions.
PURPLE SURGICAL INTERNATIONAL LIMITED
PS5475ULT
In Commercial Distribution

  • 55051223023376 ()
  • 35051223023372 ()
  • 05051223023371 ()

  • 5mm diameter x70mm length
PS5475ULT

  • Laparoscopic access cannula, single-use
The re-usable Irrigation pump is a pneumatically operated device that has been designed to apply a pre set controlled pressure to 500ml – 1000ml size bags of saline solution (not supplied), enabling precise delivery of irrigation fluid during laparoscopic procedures utilising one of the Purple Surgical Suction & Irrigation sets (PS3800, PS3801, PS3850ULT or, PS3851ULT).
PURPLE SURGICAL INTERNATIONAL LIMITED
PS3871
In Commercial Distribution

  • 05051223022497 ()
PS3871

  • Irrigation solution pressure infusor
The Ultimate Endo Retrieval Pouch is used during laparoscopic procedures for retrieving tissue specimens from the abdominal cavity.
PURPLE SURGICAL INTERNATIONAL LIMITED
PS3442ULT
In Commercial Distribution

  • 55051223022379 ()
  • 35051223022375 ()
  • 05051223022374 ()

  • Length: 145 Millimeter
  • Width: 90 Millimeter
  • Total Volume: 250 Milliliter
PS3442ULT

  • Tissue extraction bag
The Ultimate Dilating Tip Trocar has applications in minimally invasive surgical procedures to establish a path of entry for endoscopic instruments. The trocar may be used for primary and secondary insertions.
PURPLE SURGICAL INTERNATIONAL LIMITED
PS5465ULT
In Commercial Distribution

  • 55051223015531 ()
  • 35051223015537 ()
  • 05051223015536 ()

  • 5mm diameter x 100mm length
PS5465ULT

  • Laparoscopic access cannula, single-use
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