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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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MacroCast™ fine perfo, 3-precut, O-profiles
MACROMEDICS B.V.
OLMCF-3Pc
In Commercial Distribution

  • 08719425701561 ()
  • 08719425706528 ()


  • Patient positioning thermoplastic mould material
MacroCast™ fine perfo, 5-precut, L-profiles
MACROMEDICS B.V.
LMCF-5Pc
In Commercial Distribution

  • 08719425706214 ()
  • 08719425701486 ()


  • Patient positioning thermoplastic mould material
MacroCast™ fine perfo, 4-precut, L-profiles
MACROMEDICS B.V.
LMCF-4Pc
In Commercial Distribution

  • 08719425706207 ()
  • 08719425701479 ()


  • Patient positioning thermoplastic mould material
MacroCast™ fine perfo, 3-precut, L-profiles
MACROMEDICS B.V.
LMCF-3Pc
In Commercial Distribution

  • 08719425701455 ()
  • 08719425706184 ()


  • Patient positioning thermoplastic mould material
MacroCast™ fine perfo, 2-precut, L-profiles
MACROMEDICS B.V.
LMCF-2Pc
In Commercial Distribution

  • 08719425706177 ()


  • Patient positioning thermoplastic mould material
SSPS Mask head only, Type-VRT, open face
MACROMEDICS B.V.
SSPS-FVRPc
In Commercial Distribution

  • 08719425705743 ()
  • 08719425701240 ()


  • Patient positioning thermoplastic mould material
SSPS Mask Type-S or RealEase head and shoulder
MACROMEDICS B.V.
SSPS-FSSPc
In Commercial Distribution

  • 08719425705729 ()


  • Patient positioning thermoplastic mould material
SSPS Mask head only for long hair
MACROMEDICS B.V.
SSPS-FLPc
In Commercial Distribution

  • 08719425701226 ()
  • 08719425705682 ()


  • Patient positioning thermoplastic mould material
SSPS Mask head only
MACROMEDICS B.V.
SSPS-FPc
In Commercial Distribution

  • 08719425701097 ()
  • 08719425705668 ()
  • 08719425701219 ()


  • Patient positioning thermoplastic mould material
DSPS Prominent Mask Set Supine, head and shoulder for long hair
MACROMEDICS B.V.
DSPS-PROSLPc
In Commercial Distribution

  • 08720168162281 ()
113980M

  • Patient positioning thermoplastic mould material
DSPS Prominent Mask Set Supine, head and shoulder for long hair, open face
MACROMEDICS B.V.
DSPS-PROSVRLPc
In Commercial Distribution

  • 08720168162274 ()
113950M

  • Patient positioning thermoplastic mould material
DSPS Prominent Mask Set Supine, head and shoulder for long hair, set of 5
MACROMEDICS B.V.
DSPS-PROSL
In Commercial Distribution

  • 08720168162267 ()
113980

  • Patient positioning thermoplastic mould material
DSPS Prominent Mask Set Supine, head and shoulder for long hair, open face, set of 5
MACROMEDICS B.V.
DSPS-PROSVRL
In Commercial Distribution

  • 08720168162250 ()
113950

  • Patient positioning thermoplastic mould material
DSPS Prominent Mask Set Supine, head and shoulder, open face
MACROMEDICS B.V.
DSPS-PROSVRPc
In Commercial Distribution

  • 08720168162243 ()
113970M

  • Patient positioning thermoplastic mould material
DSPS Prominent Mask Set Supine, head and shoulder, open face, set of 5
MACROMEDICS B.V.
DSPS-PROSVR
In Commercial Distribution

  • 08720168162236 ()
113970

  • Patient positioning thermoplastic mould material
Occipital Mask Prominent, head and shoulder
MACROMEDICS B.V.
DSPS-PROPc
In Commercial Distribution

  • 08720168162229 ()
113990M

  • Patient positioning thermoplastic mould material
DSPS Prominent Mask Set Supine, head and shoulder
MACROMEDICS B.V.
DSPS-PROSPc
In Commercial Distribution

  • 08720168162212 ()
113960M

  • Patient positioning thermoplastic mould material
DSPS Prominent Mask Set Supine, head and shoulder, set of 5
MACROMEDICS B.V.
DSPS-PROS
In Commercial Distribution

  • 08720168162205 ()
113960

  • Patient positioning thermoplastic mould material
The disposable single-use Lavage Procedure Kit consists of a Tubing Set, Cannulae, Temperature Probes and a Fluid Reservoir. The Lavage Procedure Kit is supplied sterile.
Eight Medical International B.V.
1
Not in Commercial Distribution

  • 08719992086016 ()


  • Extravascular-circulation hyperthermia system applicator, intracorporeal
The Recirculator 8.0 is comprised of two components: a portable control console and a single use disposable. The Console consists of a heater, pump, user touch screen, microprocessor, and interface electronics. The primary user interface is a color touch screen display that allows the user to make selections from the operating screen consisting of message display area, main screen area and flow control area. The touch screen also displays operating conditions, flow rate, output fluid temperature, patient temperature, target temperature, alarm and status messages, various timers and auxiliary temperatures. The Recirculator 8.0 monitors various sensors in the fluid path to ensure safe operation and alerts the user with alarms for out of specification conditions. Independent protection circuits prevent unsafe operation in the event of system software fault. The disposable single-use Lavage Procedure Kit consists of a Tubing Set, Cannulae, Temperature Probes and a Fluid Reservoir. The Lavage Procedure Kit is supplied sterile.
Eight Medical International B.V.
8.0
Not in Commercial Distribution

  • 08719992086009 ()


  • Extravascular-circulation hyperthermia system applicator, intracorporeal
No Description
Merchsource, LLC
1018016
In Commercial Distribution

  • 00840397501137 ()


  • Foot bath
Low pressure tube, CO2, 6 m
Karl Storz GmbH & Co. KG
UI003
In Commercial Distribution

  • 04048551326558 ()


  • Insufflation gas conditioning tubing set
Low Pressure Tube, CO2, 150 cm
Karl Storz GmbH & Co. KG
UI001
In Commercial Distribution

  • 04048551326534 ()


  • Insufflation gas conditioning tubing set
Protocol Administration Set with Small Catheter and Retention Cuff CO2 Delivery System for Colon Insufflation
Bracco Diagnostics Inc.
390402
In Commercial Distribution

  • 30815112021284 ()
  • 10815112021280 ()

  • Catheter Gauge: 20 French
390402

  • Insufflation gas conditioning tubing set
Protocol Touch Administration Set w/20 Fr. Tip
Bracco Diagnostics Inc.
390309
In Commercial Distribution

  • 30815112021246 ()
  • 10815112021242 ()

  • Catheter Gauge: 20 French
390309

  • Insufflation gas conditioning tubing set
Protocol Administration Set with Small Catheter and Retention Cuff CO2 Delivery System for Colon Insufflation
Bracco Diagnostics Inc.
390402
In Commercial Distribution

  • 30815112020171 ()
  • 10815112020177 ()

  • Catheter Gauge: 20 French
390402

  • Insufflation gas conditioning tubing set
Protocol Touch Administration Set we/20fr. Tip
Bracco Diagnostics Inc.
390309
In Commercial Distribution

  • 10815112020153 ()
  • 30815112020157 ()
390309

  • Insufflation gas conditioning tubing set
Dental Implant Instrument / Guide Wheel Initial Drill
DENTIS CO. ,LTD
DGWID20
In Commercial Distribution

  • 08800053023054 ()


  • Patient positioning thermoplastic mould material
ZMD-1000B Castable
DENTIS CO. ,LTD
ZMD-1000B Castable
In Commercial Distribution

  • 08800053014212 ()


  • Patient positioning thermoplastic mould material
Solid Bolus
CDR Systems Inc
1
In Commercial Distribution

  • 10628341930410 ()
  • 00628341930413 ()
S-Bolus

  • Patient positioning thermoplastic mould material
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