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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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
Solid Bolus
CDR Systems Inc
1
In Commercial Distribution

  • 00628341930406 ()
  • 10628341930403 ()
S-Bolus

  • Patient positioning thermoplastic mould material
Thermoplastic Immobilization Mask
CDR Systems Inc
1
Not in Commercial Distribution

  • 10628341930380 ()
  • 00628341930383 ()


  • Patient positioning thermoplastic mould material
Thermoplastic Immobilization Materials
CDR Systems Inc
1
Not in Commercial Distribution

  • 10628341930373 ()
  • 00628341930376 ()


  • Patient positioning thermoplastic mould material
Thermoplastic Immobilization Materials
CDR Systems Inc
1
In Commercial Distribution

  • 10628341930229 ()
  • 00628341930222 ()


  • Patient positioning thermoplastic mould material
No Description
BELMONT INSTRUMENT CORPORATION
902-00048
In Commercial Distribution

  • 10896128002579 ()


  • Extravascular-circulation hyperthermia system applicator, intracorporeal
No Description
BELMONT INSTRUMENT CORPORATION
902-00043
Not in Commercial Distribution

  • 10896128002296 ()


  • Extravascular-circulation hyperthermia system applicator, intracorporeal
No Description
BELMONT INSTRUMENT CORPORATION
902-00036
In Commercial Distribution

  • 10896128002289 ()


  • Extravascular-circulation hyperthermia system applicator, intracorporeal
No Description
BELMONT INSTRUMENT CORPORATION
902-00004
Not in Commercial Distribution

  • 10896128002265 ()


  • Extravascular-circulation hyperthermia system applicator, intracorporeal
Sentosa SA201 HSV-1/2 PCR Test is a real-time PCR based in vitro diagnostic test to detect and differentiate HSV1 and HSV2 virus DNA qualitatively.
VELA OPERATIONS SINGAPORE PTE. LTD.
300216
In Commercial Distribution

  • 08885013953664 ()
300216

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory, semi-automated
The Sentosa SA201 Real-Time PCR Instrument is a real-time nucleic acid amplification and detection system. It measures nucleic acid signals from reverse transcribed RNA and converts the signals to comparative quantitative readouts using fluorescent detection of dual-labeled hydrolysis probes.
VELA OPERATIONS SINGAPORE PTE. LTD.
400125
In Commercial Distribution

  • 08885013950021 ()
400125

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory, semi-automated
No Description
Merchsource, LLC
1017475
In Commercial Distribution

  • 00843479186611 ()


  • Foot bath
No Description
Merchsource, LLC
1014496, 1017308
In Commercial Distribution

  • 00843479153910 ()


  • Foot bath
No Description
Merchsource, LLC
1014495
In Commercial Distribution

  • 00843479153903 ()


  • Foot bath
Latex Free 10 ft Insufflation tubing, Small Direct Connector w .1 Micron Filter Sterile one time use,
Surgical Direct, Inc.
SD500-04s
In Commercial Distribution

  • B382SD50004S0 ()
SD500-04s

  • Insufflation gas conditioning tubing set
Latex Free 10 ft Insufflation tubing, Small Direct Connector w .1 Micron Filter Sterile one time use,
Surgical Direct, Inc.
SD500- 04
In Commercial Distribution

  • B382SD500041 ()
SD500- 04

  • Insufflation gas conditioning tubing set
Latex Free 10 ft Insufflation tubing, 22mm Direct Connector w .1 Micron Filter Sterile one time use, 1
Surgical Direct, Inc.
SD500-03s
In Commercial Distribution

  • B382SD50003S0 ()
SD500-03s

  • Insufflation gas conditioning tubing set
Latex Free 10 ft Insufflation Tubing, High Flow Connector W/.1 Micron Filter, Sterile One Time Use, 1
Surgical Direct, Inc.
SD500-02s
In Commercial Distribution

  • B382SD50002S0 ()
SD500-02s

  • Insufflation gas conditioning tubing set
Latex Free 10 ft insufflation tubing, High Flow Connector w .1 Micron Filter, Sterile, one time use, 2
Surgical Direct, Inc.
SD500-02
In Commercial Distribution

  • B382SD500021 ()
SD500-02

  • Insufflation gas conditioning tubing set
.1 Micron Filter High Flow Insufflation Tubing, 10 ft Long, Latex Free, Colder Connector, Sterile, Sin
Surgical Direct, Inc.
SD500-01s
In Commercial Distribution

  • B382SD50001S0 ()
SD500-01s

  • Insufflation gas conditioning tubing set
Latex Free 10 ft insufflation tubing, Colder Connector w .1 Micron Filter Sterile one time use, 10 uni
Surgical Direct, Inc.
SD500-01m
In Commercial Distribution

  • B382SD50001M0 ()
SD500-01m

  • Insufflation gas conditioning tubing set
Latex Free 10 ft insufflation tubing, Colder Connector with 1 Micron Filter Sterile one time use, 20 u
Surgical Direct, Inc.
SD500-01
In Commercial Distribution

  • B382SD500011 ()
SD500-01

  • Insufflation gas conditioning tubing set
.1 Micron Filter High Flow Insufflation Tubing 10 ft Long Latex Free Sterile, Single Use, Sample
Surgical Direct, Inc.
SD500-00s
In Commercial Distribution

  • B382SD50000S0 ()
SD500-00s

  • Insufflation gas conditioning tubing set
Latex Free 10 ft insufflation tubing Luer Lock connector w .1 Micron Filter Sterile one time use, 10 u
Surgical Direct, Inc.
SD500-00m
In Commercial Distribution

  • B382SD50000M0 ()
SD500-00m

  • Insufflation gas conditioning tubing set
Latex Free 10 ft insufflation tubing Luer Lock connector w .1 Micron Filter Sterile one time use, 20 u
Surgical Direct, Inc.
SD500-00
In Commercial Distribution

  • B382SD500001 ()
SD500-00

  • Insufflation gas conditioning tubing set
Integra® MicroFrance® Silicon cap for luer-lock connection (Pk 6)
INTEGRA MICROFRANCE
CEV57
In Commercial Distribution

  • 10381780094012 ()
  • 00381780094015 ()
CEV57

  • Insufflation gas conditioning tubing set
Power Cord US 2-Pole Demo
Avanos Medical, Inc.
303659-DM
In Commercial Distribution

  • 00812120004017 ()
303659-DM

  • Circulating-fluid localized thermal/compression therapy system wrap
Power Cord US 2-Pole Rental
Avanos Medical, Inc.
303659-RN
In Commercial Distribution

  • 00812120003997 ()
303659-RN

  • Circulating-fluid localized thermal/compression therapy system wrap
Connector Hose 6 ft Sport Rental
Avanos Medical, Inc.
570300-RN
In Commercial Distribution

  • 00812120003980 ()
570300-RN

  • Circulating-fluid localized thermal/compression therapy system wrap
590906-03-RN ATX WRAP HALF LEG BOOT LG RNTL,1
Avanos Medical, Inc.
590906-03-RN
In Commercial Distribution

  • 00812120003935 ()
590906-03-RN

  • Circulating-fluid localized thermal/compression therapy system wrap
303945-EX01 Accessory Kit, Med4 Elite, NA, ES
Avanos Medical, Inc.
303945-EX01
In Commercial Distribution

  • 00812120003706 ()
303945-EX01

  • Circulating-fluid localized thermal/compression therapy system wrap
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