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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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GENERATOR 6800001AMR CARDIOBLATE EN
MEDTRONIC, INC.
6800001AMR
In Commercial Distribution

  • 00643169121850 ()


  • Percutaneous radio-frequency ablation system generator
NeoGen 25mm 3x Nozzle (Grey)
ENERGIST LIMITED
NeoGen 25mm 3x Nozzle (Grey)
In Commercial Distribution

  • 15060440520263 ()
  • 05060440520266 ()
830-060

  • Nitrogen plasma skin surface treatment system
NeoGen 5mm 3x Nozzle (Grey)
ENERGIST LIMITED
NeoGen 5mm 3x Nozzle (Grey)
In Commercial Distribution

  • 15060440520256 ()
  • 05060440520259 ()
830-059

  • Nitrogen plasma skin surface treatment system
NeoGen 25mm 3x Nozzle (Black)
ENERGIST LIMITED
NeoGen 25mm 3x Nozzle (Black)
In Commercial Distribution

  • 15060440520249 ()
  • 05060440520242 ()
830-058

  • Nitrogen plasma skin surface treatment system
NeoGen 5mm 3x Nozzle (Black)
ENERGIST LIMITED
NeoGen 5mm 3x Nozzle (Black)
In Commercial Distribution

  • 15060440520232 ()
  • 05060440520235 ()
830-057

  • Nitrogen plasma skin surface treatment system
NeoGen 25mm 1x Nozzle (Grey)
ENERGIST LIMITED
NeoGen 25mm 1x Nozzle (Grey)
In Commercial Distribution

  • 15060440520225 ()
  • 05060440520228 ()
830-023

  • Nitrogen plasma skin surface treatment system
NeoGen 5mm 1x Nozzle (Grey)
ENERGIST LIMITED
NeoGen 5mm 1x Nozzle (Grey)
In Commercial Distribution

  • 15060440520218 ()
  • 05060440520211 ()
830-033

  • Nitrogen plasma skin surface treatment system
NeoGen 25mm 1x Nozzle (Black)
ENERGIST LIMITED
NeoGen 25mm 1x Nozzle (Black)
In Commercial Distribution

  • 15060440520201 ()
  • 05060440520204 ()
830-024

  • Nitrogen plasma skin surface treatment system
NeoGen 5mm 1x Nozzle (Black)
ENERGIST LIMITED
NeoGen 5mm 1x Nozzle (Black)
In Commercial Distribution

  • 15060440520195 ()
  • 05060440520198 ()
830-006

  • Nitrogen plasma skin surface treatment system
MAIN,ALS,MAN-1,3/5 LD,STD ECG,AC PWR,SPO2,ETCO2,PACE,NIBP,CF/USB,R SERIES
Zoll Medical Corporation
30000000520131012
In Commercial Distribution

  • 00847946001872 ()

  • 10.2" X 10.3" X 8.7"


  • Rechargeable professional automated external defibrillator
OBALON® Recalibration Tool - component for use with the OBALON® Navigation Console
Reshape Lifesciences Inc.
7405-0001
Not in Commercial Distribution

  • 00859810006241 ()


  • Gastrointestinal catheter/endoscope tracking system
OBALON® Reference Sensor Cable - component for use with the OBALON® Navigation Console
Reshape Lifesciences Inc.
7404-0001
Not in Commercial Distribution

  • 00859810006197 ()


  • Gastrointestinal catheter/endoscope tracking system sensor, body-surface
The Joovv Go 2.0 is a handheld phototherapy device that emits light in the Red and Near Infrared spectrum.
JOOVV, INC.
PT500-F0488
In Commercial Distribution

  • 00855501008280 ()


  • Blue/red/infrared phototherapy lamp
The Joovv Mini 3.0 is a portable phototherapy device that emits light in the Red and Near Infrared spectrum.
JOOVV, INC.
PT500-F0487
In Commercial Distribution

  • 00855501008273 ()


  • Blue/red/infrared phototherapy lamp
The Joovv Solo 3.0 is a portable phototherapy device that emits light in the Red and Near Infrared spectrum.
JOOVV, INC.
PT500-F0486
In Commercial Distribution

  • 10855501008263 ()
  • 00855501008266 ()


  • Blue/red/infrared phototherapy lamp
GIJaw Single-Use Biopsy Forceps with Needle
DIVERSATEK HEALTHCARE, INC.
1190-04
In Commercial Distribution

  • 10816734023126 ()
  • 00816734023129 ()
  • 20816734023123 ()

  • Length: 230 Centimeter
  • Width: 2.8 Millimeter
1190-04

  • Flexible endoscopic biopsy forceps, single-use
AIR-FLOW® handy 3.0
E.M.S. Electro Medical Systems S.A.
B
In Commercial Distribution

  • 07613353221560 ()
FT-220#NA/005

  • Dental abrasive air jet system handpiece
No Description
Advanced Bionics, LLC
CI-1605
In Commercial Distribution



  • Cochlear electrode array depth gauge, single-use
CBL, 4WIRE LIMB LEAD-5FTAHA, 12 LEAD ECG 3RD ED
PHYSIO-CONTROL, INC.
11111
In Commercial Distribution

  • 00883873940518 ()

  • Length: 5 Feet
11111-000018

  • Electrocardiographic lead set, reusable
CBL, 4WIRE LIMB LEAD-5FTIEC, 12 LEAD ECG 3RD ED
PHYSIO-CONTROL, INC.
11111
In Commercial Distribution

  • 00883873940501 ()

  • Length: 5 Feet
11111-000019

  • Electrocardiographic lead set, reusable
CBL, 4WIRE LIMB LEAD-8FTAHA, 12 LEAD ECG 3RD ED
PHYSIO-CONTROL, INC.
11111
In Commercial Distribution

  • 00883873940495 ()

  • Length: 8 Feet
11111-000020

  • Electrocardiographic lead set, reusable
CBL, 4WIRE LIMB LEAD-8FTIEC, 12 LEAD ECG 3RD ED
PHYSIO-CONTROL, INC.
11111
In Commercial Distribution

  • 00883873940488 ()

  • Length: 8 Feet
11111-000021

  • Electrocardiographic lead set, reusable
CABLE, 6WIRE PRECORDIAL-AHA, 12 LEAD ECG, 3RD ED
PHYSIO-CONTROL, INC.
11111
In Commercial Distribution

  • 00883873940471 ()
11111-000022

  • Electrocardiographic lead set, reusable
CABLE, 6 WIRE PRECORDIAL- IEC, 12 LEAD ECG
PHYSIO-CONTROL, INC.
11111
In Commercial Distribution

  • 00883873940464 ()
11111-000023

  • Electrocardiographic lead set, reusable
KIT, LARGE. Includes: 100 - BLOCK, TORSO, 7” x 12” x 16” (00810050243049), 101 - BLOCK, BASALAR, 7” x 16” x 12” (00810050240987), 102 - HOLDER, ADULT AP-PA HEAD (00810050241205), 104 - BLOCK, PRESSURE, 5.5” x 7.38” x 10” (00810050241069), 105 - WEDGE, 3.75” x 9” x 8” (10810050242995), 106 - WEDGE, 6.63” x 6.63” x 12” (00810050242318), 169 - RECTANGLE, 3” x 7.5” x 10” (00810050240413)
DOMICO MED-DEVICE, LLC
2
In Commercial Distribution

  • 00810050243254 ()


  • Multifunction body cushion
  • Radiological general body-part positioner
  • Radiological headrest
The Micro Well Group Culture Dish is designed for efficient embryo handling and culture. The sixteen (16) microwells are intended for embryo culture at all stages. The wells are intended to hold one embryo each. The area surrounding the wells can contain a sufficient amount of culture medium for all embryos, thereby allowing efficient culture setup and handling. The individual microwells allows individual evaluation of each embryo during group culture. The Micro Well Group Culture Dish is constructed of polysterene and is non-pyrogenic. The raw material has passed mouse embryo testing prior to production and the dish is sterilised by beta irradiation. Sterility Assurance level 10-6 (SAL 10-6). Indications for Use / Intended Use: For in vitro fertilisation, handling and embryo culture. It may be used for culturing of embryos using drop culture.
Vitrolife A/S
16606
In Commercial Distribution

  • 05712714666063 ()
  • 15712714666060 ()
16606

  • Assisted reproduction procedure dish
The Micro Well Group Culture Dish is designed for efficient embryo handling and culture. The nine (9) microwells are intended for embryo culture at all stages. The wells are intended to hold one embryo each. The area surrounding the wells can contain a sufficient amount of culture medium for all embryos, thereby allowing efficient culture setup and handling. The individual microwells allows individual evaluation of each embryo during group culture. The Micro Well Group Culture Dish is constructed of polysterene and is non-pyrogenic. The raw material has passed mouse embryo testing prior to production and the dish is sterilised by beta irradiation. Sterility Assurance level 10-6 (SAL 10-6). Indications for Use / Intended Use: For in vitro fertilisation, handling and embryo culture. It may be used for culturing of embryos using drop culture.
Vitrolife A/S
16604
In Commercial Distribution

  • 05712714666049 ()
  • 15712714666046 ()
16604

  • Assisted reproduction procedure dish
Probe
FUJIFILM CORPORATION
UST-2266-5
In Commercial Distribution



  • Extracorporeal ultrasound imaging transducer, hand-held
Probe
FUJIFILM CORPORATION
L51K
In Commercial Distribution



  • Surgical ultrasound imaging transducer
Audio Processor Kit (without headband)
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
38203
Not in Commercial Distribution

  • 09008737382032 ()


  • Bone-conduction hearing aid, head-worn
Audio Processor Kit (without headband)
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
38202
Not in Commercial Distribution

  • 09008737382025 ()


  • Bone-conduction hearing aid, head-worn
Audio Processor Kit (without headband)
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
38201
Not in Commercial Distribution

  • 09008737382018 ()


  • Bone-conduction hearing aid, head-worn
Audio Processor Kit (without headband)
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
38200
Not in Commercial Distribution

  • 09008737382001 ()


  • Bone-conduction hearing aid, head-worn
Audio Processor Kit
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
38199
In Commercial Distribution

  • 09008737381998 ()


  • Bone-conduction hearing aid, head-worn
Audio Processor Kit
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
38198
In Commercial Distribution

  • 09008737381981 ()


  • Bone-conduction hearing aid, head-worn
Audio Processor Kit
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
38197
In Commercial Distribution

  • 09008737381974 ()


  • Bone-conduction hearing aid, head-worn
Audio Processor Kit
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
38196
In Commercial Distribution

  • 09008737381967 ()


  • Bone-conduction hearing aid, head-worn
Magna R3 LOGIQ F Basic console
GE Medical Systems (China) Co.,Ltd.
LOGIQ F R3
In Commercial Distribution

  • 00195278722430 ()


  • General-purpose ultrasound imaging system
Magna R3 LOTUS 5pp Basic console
GE Medical Systems (China) Co.,Ltd.
Premier LOTUS 5PP
In Commercial Distribution

  • 00195278690418 ()


  • General-purpose ultrasound imaging system
Magna R3 LOTUS 4pp Basic console
GE Medical Systems (China) Co.,Ltd.
Premier LOTUS 4PP
In Commercial Distribution

  • 00195278690401 ()


  • General-purpose ultrasound imaging system
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