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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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
BUR-ROUND CARB 3mm,MEDIUM
DE SOUTTER MEDICAL LIMITED
R15-107
In Commercial Distribution

  • 15051471027340 ()
  • 05051471027343 ()
R15-107

  • Orthopaedic bur, 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
BUR-ROUND CARB 1.5mm,MEDIUM
DE SOUTTER MEDICAL LIMITED
R15-102
In Commercial Distribution

  • 15051471027265 ()
  • 05051471027268 ()
R15-102

  • Orthopaedic bur, 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
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
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 probe attached to the Laparoscopic Suction / Irrigation Set can be used during a variety of laparoscopic procedures to irrigate and remove fluid from the operating site, in the function of one instrument.
PURPLE SURGICAL INTERNATIONAL LIMITED
PS3845ULT
In Commercial Distribution

  • 35051223007945 ()
  • 05051223007944 ()

  • Length: 440 Millimeter
PS3845ULT

  • Surgical irrigation/aspiration tubing set
The probe attached to the Laparoscopic Suction / Irrigation Set can be used during a variety of laparoscopic procedures to irrigate and remove fluid from the operating site, in the function of one instrument.
PURPLE SURGICAL INTERNATIONAL LIMITED
PS3835ULT
In Commercial Distribution

  • 55051223007925 ()
  • 35051223007921 ()
  • 05051223007920 ()

  • Length: 170 Millimeter
PS3835ULT

  • Surgical irrigation/aspiration tubing set
The probe attached to the Laparoscopic Suction / Irrigation Set can be used during a variety of laparoscopic procedures to irrigate and remove fluid from the operating site, in the function of one instrument.
PURPLE SURGICAL INTERNATIONAL LIMITED
PS3853ULT
In Commercial Distribution

  • 35051223007365 ()
  • 05051223007364 ()

  • Length: 320 Millimeter
PS3853ULT

  • Surgical irrigation/aspiration tubing set
The probe attached to the Laparoscopic Suction / Irrigation Set can be used during a variety of laparoscopic procedures to irrigate and remove fluid from the operating site, in the function of one instrument. The 10mm diameter probe is designed for use with the PS3850ULT & PS3851ULT suction irrigation sets. It is to be used in place of the standard 5mm diameter detachable probe which is originally supplied with the suction irrigation set, in instances where a 10mm probe provides surgical advantages.
PURPLE SURGICAL INTERNATIONAL LIMITED
PS3852ULT
In Commercial Distribution

  • 05051223006046 ()

  • Length: 333 Millimeter
PS3852ULT

  • Surgical irrigation/aspiration tubing set
Suction / Irrigation Set can be used during a variety of laparoscopic procedures to irrigate and remove fluid from the operating site, in the function of one instrument.
PURPLE SURGICAL INTERNATIONAL LIMITED
PS3851ULT
In Commercial Distribution

  • 35051223005774 ()
  • 05051223005773 ()

  • Length: 320 Millimeter
PS3851ULT

  • Surgical irrigation/aspiration tubing set
Dual spike Suction / Irrigation Set can be used during a variety of laparoscopic procedures to irrigate and remove fluid from the operating site, in the function of one instrument.
PURPLE SURGICAL INTERNATIONAL LIMITED
PS3850ULT
In Commercial Distribution

  • 05051223005759 ()
  • 35051223005750 ()

  • Length: 320 Millimeter
PS3850ULT

  • Surgical irrigation/aspiration tubing set
The probe attached to the Laparoscopic Suction / Irrigation Set can be used during a variety of laparoscopic procedures to irrigate and remove fluid from the operating site, in the function of one instrument. The 10mm diameter probe is designed for use with the PS3800 & PS3801 suction irrigation sets. It is to be used in place of the standard 5mm diameter detachable probe which is originally supplied with the suction irrigation set, in instances where a 10mm probe provides surgical advantages.
PURPLE SURGICAL INTERNATIONAL LIMITED
PS3852
In Commercial Distribution

  • 05051223004202 ()

  • Length: 333 Millimeter
PS3852

  • Surgical irrigation/aspiration tubing set
The Laparoscopic Suction / Irrigation Set can be used during a variety of laparoscopic procedures to irrigate and remove fluid from the operating site, in the function of one instrument.
PURPLE SURGICAL INTERNATIONAL LIMITED
PS3801
In Commercial Distribution

  • 35051223004197 ()
  • 05051223004196 ()
PS3801

  • Surgical irrigation/aspiration tubing set
The Laparoscopic Suction / Irrigation Set can be used during a variety of laparoscopic procedures to irrigate and remove fluid from the operating site, in the function of one instrument.
PURPLE SURGICAL INTERNATIONAL LIMITED
PS3800
In Commercial Distribution

  • 35051223004180 ()
  • 05051223004189 ()

  • Length: 320 Millimeter
PS3800

  • Surgical irrigation/aspiration tubing set
SLEEP SYSTEM NITETIME
THE HELPING HAND COMPANY (LEDBURY) LIMITED
SYMMSLYDE
In Commercial Distribution

  • 05050962170971 ()
SA90

  • Assistive sleeping cushion set
SLEEP SYSTEM NITETIME
THE HELPING HAND COMPANY (LEDBURY) LIMITED
LOWER LIMB POSITIONING ITEMS
In Commercial Distribution

  • 05050962140691 ()
SA5520

  • Assistive sleeping cushion set
SLEEP SYSTEM NITETIME
THE HELPING HAND COMPANY (LEDBURY) LIMITED
LOWER LIMB POSITIONING ITEMS
In Commercial Distribution

  • 05050962140622 ()
SA5520SUS

  • Assistive sleeping cushion set
No Description
THE HELPING HAND COMPANY (LEDBURY) LIMITED
LOWER LIMB POSITIONING ITEMS
In Commercial Distribution

  • 05050962140530 ()
SA5540S

  • Assistive sleeping cushion set
SLEEP SYSTEM NITETIME
THE HELPING HAND COMPANY (LEDBURY) LIMITED
POSITIONING BRACKET PAD
In Commercial Distribution

  • 05050962031241 ()
SA719

  • Assistive sleeping cushion set
SLEEP SYSTEM NITETIME
THE HELPING HAND COMPANY (LEDBURY) LIMITED
'A' CUSHION_SPECIAL
In Commercial Distribution

  • 05050962013520 ()
SA79

  • Assistive sleeping cushion set
SMARTLOAD TECNIS EYHANCE US IOL 34.0D
JOHNSON & JOHNSON SURGICAL VISION, INC.
GIB00
In Commercial Distribution

  • 05050474830158 ()

  • OPTICAL ZONE DIAMETER:6.00 mm
  • Outer Diameter: 13.00 Millimeter
  • OPTICAL POWER:34.00 DIO
GIB00U0340

  • Posterior-chamber intraocular lens, pseudophakic
SMARTLOAD TECNIS EYHANCE US IOL 33.5D
JOHNSON & JOHNSON SURGICAL VISION, INC.
GIB00
In Commercial Distribution

  • 05050474830141 ()

  • OPTICAL POWER:33.50 DIO
  • Outer Diameter: 13.00 Millimeter
  • OPTICAL ZONE DIAMETER:6.00 mm
GIB00U0335

  • Posterior-chamber intraocular lens, pseudophakic
SMARTLOAD TECNIS EYHANCE US IOL 33.0D
JOHNSON & JOHNSON SURGICAL VISION, INC.
GIB00
In Commercial Distribution

  • 05050474830134 ()

  • OPTICAL POWER:33.00 DIO
  • OPTICAL ZONE DIAMETER:6.00 mm
  • Outer Diameter: 13.00 Millimeter
GIB00U0330

  • Posterior-chamber intraocular lens, pseudophakic
SMARTLOAD TECNIS EYHANCE US IOL 32.5D
JOHNSON & JOHNSON SURGICAL VISION, INC.
GIB00
In Commercial Distribution

  • 05050474830127 ()

  • Outer Diameter: 13.00 Millimeter
  • OPTICAL POWER:32.50 DIO
  • OPTICAL ZONE DIAMETER:6.00 mm
GIB00U0325

  • Posterior-chamber intraocular lens, pseudophakic
SMARTLOAD TECNIS EYHANCE US IOL 32.0D
JOHNSON & JOHNSON SURGICAL VISION, INC.
GIB00
In Commercial Distribution

  • 05050474830110 ()

  • Outer Diameter: 13.00 Millimeter
  • OPTICAL POWER:32.00 DIO
  • OPTICAL ZONE DIAMETER:6.00 mm
GIB00U0320

  • Posterior-chamber intraocular lens, pseudophakic
SMARTLOAD TECNIS EYHANCE US IOL 31.5D
JOHNSON & JOHNSON SURGICAL VISION, INC.
GIB00
In Commercial Distribution

  • 05050474830103 ()

  • Outer Diameter: 13.00 Millimeter
  • OPTICAL POWER:31.50 DIO
  • OPTICAL ZONE DIAMETER:6.00 mm
GIB00U0315

  • Posterior-chamber intraocular lens, pseudophakic
SMARTLOAD TECNIS EYHANCE US IOL 31.0D
JOHNSON & JOHNSON SURGICAL VISION, INC.
GIB00
In Commercial Distribution

  • 05050474830097 ()

  • OPTICAL ZONE DIAMETER:6.00 mm
  • Outer Diameter: 13.00 Millimeter
  • OPTICAL POWER:31.00 DIO
GIB00U0310

  • Posterior-chamber intraocular lens, pseudophakic
SMARTLOAD TECNIS EYHANCE US IOL 30.5D
JOHNSON & JOHNSON SURGICAL VISION, INC.
GIB00
In Commercial Distribution

  • 05050474830080 ()

  • OPTICAL ZONE DIAMETER:6.00 mm
  • Outer Diameter: 13.00 Millimeter
  • OPTICAL POWER:30.50 DIO
GIB00U0305

  • Posterior-chamber intraocular lens, pseudophakic
SMARTLOAD TECNIS EYHANCE US IOL 30.0D
JOHNSON & JOHNSON SURGICAL VISION, INC.
GIB00
In Commercial Distribution

  • 05050474830073 ()

  • OPTICAL POWER:30.00 DIO
  • Outer Diameter: 13.00 Millimeter
  • OPTICAL ZONE DIAMETER:6.00 mm
GIB00U0300

  • Posterior-chamber intraocular lens, pseudophakic
SMARTLOAD TECNIS EYHANCE US IOL 29.5D
JOHNSON & JOHNSON SURGICAL VISION, INC.
GIB00
In Commercial Distribution

  • 05050474830066 ()

  • OPTICAL ZONE DIAMETER:6.00 mm
  • OPTICAL POWER:29.50 DIO
  • Outer Diameter: 13.00 Millimeter
GIB00U0295

  • Posterior-chamber intraocular lens, pseudophakic
SMARTLOAD TECNIS EYHANCE US IOL 29.0D
JOHNSON & JOHNSON SURGICAL VISION, INC.
GIB00
In Commercial Distribution

  • 05050474830059 ()

  • OPTICAL ZONE DIAMETER:6.00 mm
  • Outer Diameter: 13.00 Millimeter
  • OPTICAL POWER:29.00 DIO
GIB00U0290

  • Posterior-chamber intraocular lens, pseudophakic
SMARTLOAD TECNIS EYHANCE US IOL 28.5D
JOHNSON & JOHNSON SURGICAL VISION, INC.
GIB00
In Commercial Distribution

  • 05050474830042 ()

  • OPTICAL ZONE DIAMETER:6.00 mm
  • OPTICAL POWER:28.50 DIO
  • Outer Diameter: 13.00 Millimeter
GIB00U0285

  • Posterior-chamber intraocular lens, pseudophakic
SMARTLOAD TECNIS EYHANCE US IOL 28.0D
JOHNSON & JOHNSON SURGICAL VISION, INC.
GIB00
In Commercial Distribution

  • 05050474830035 ()

  • Outer Diameter: 13.00 Millimeter
  • OPTICAL POWER:28.00 DIO
  • OPTICAL ZONE DIAMETER:6.00 mm
GIB00U0280

  • Posterior-chamber intraocular lens, pseudophakic
SMARTLOAD TECNIS EYHANCE US IOL 27.5D
JOHNSON & JOHNSON SURGICAL VISION, INC.
GIB00
In Commercial Distribution

  • 05050474830028 ()

  • OPTICAL POWER:27.50 DIO
  • OPTICAL ZONE DIAMETER:6.00 mm
  • Outer Diameter: 13.00 Millimeter
GIB00U0275

  • Posterior-chamber intraocular lens, pseudophakic
SMARTLOAD TECNIS EYHANCE US IOL 27.0D
JOHNSON & JOHNSON SURGICAL VISION, INC.
GIB00
In Commercial Distribution

  • 05050474830011 ()

  • Outer Diameter: 13.00 Millimeter
  • OPTICAL ZONE DIAMETER:6.00 mm
  • OPTICAL POWER:27.00 DIO
GIB00U0270

  • Posterior-chamber intraocular lens, pseudophakic
SMARTLOAD TECNIS EYHANCE US IOL 26.5D
JOHNSON & JOHNSON SURGICAL VISION, INC.
GIB00
In Commercial Distribution

  • 05050474830004 ()

  • OPTICAL ZONE DIAMETER:6.00 mm
  • Outer Diameter: 13.00 Millimeter
  • OPTICAL POWER:26.50 DIO
GIB00U0265

  • Posterior-chamber intraocular lens, pseudophakic
SMARTLOAD TECNIS EYHANCE US IOL 26.0D
JOHNSON & JOHNSON SURGICAL VISION, INC.
GIB00
In Commercial Distribution

  • 05050474829992 ()

  • OPTICAL POWER:26.00 DIO
  • Outer Diameter: 13.00 Millimeter
  • OPTICAL ZONE DIAMETER:6.00 mm
GIB00U0260

  • Posterior-chamber intraocular lens, pseudophakic
SMARTLOAD TECNIS EYHANCE US IOL 25.5D
JOHNSON & JOHNSON SURGICAL VISION, INC.
GIB00
In Commercial Distribution

  • 05050474829985 ()

  • OPTICAL POWER:25.50 DIO
  • OPTICAL ZONE DIAMETER:6.00 mm
  • Outer Diameter: 13.00 Millimeter
GIB00U0255

  • Posterior-chamber intraocular lens, pseudophakic
SMARTLOAD TECNIS EYHANCE US IOL 25.0D
JOHNSON & JOHNSON SURGICAL VISION, INC.
GIB00
In Commercial Distribution

  • 05050474829978 ()

  • Outer Diameter: 13.00 Millimeter
  • OPTICAL ZONE DIAMETER:6.00 mm
  • OPTICAL POWER:25.00 DIO
GIB00U0250

  • Posterior-chamber intraocular lens, pseudophakic
SMARTLOAD TECNIS EYHANCE US IOL 24.5D
JOHNSON & JOHNSON SURGICAL VISION, INC.
GIB00
In Commercial Distribution

  • 05050474829961 ()

  • Outer Diameter: 13.00 Millimeter
  • OPTICAL ZONE DIAMETER:6.00 mm
  • OPTICAL POWER:24.50 DIO
GIB00U0245

  • Posterior-chamber intraocular lens, pseudophakic
SMARTLOAD TECNIS EYHANCE US IOL 23.5D
JOHNSON & JOHNSON SURGICAL VISION, INC.
GIB00
In Commercial Distribution

  • 05050474829947 ()

  • OPTICAL POWER:23.50 DIO
  • OPTICAL ZONE DIAMETER:6.00 mm
  • Outer Diameter: 13.00 Millimeter
GIB00U0235

  • Posterior-chamber intraocular lens, pseudophakic
SMARTLOAD TECNIS EYHANCE US IOL 23.0D
JOHNSON & JOHNSON SURGICAL VISION, INC.
GIB00
In Commercial Distribution

  • 05050474829930 ()

  • Outer Diameter: 13.00 Millimeter
  • OPTICAL POWER:23.00 DIO
  • OPTICAL ZONE DIAMETER:6.00 mm
GIB00U0230

  • Posterior-chamber intraocular lens, pseudophakic
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