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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No Description
LIFELINES LIMITED
Trackit 3 BT 20/4/B
In Commercial Distribution

  • 05060275450059 ()
1169

  • Electroencephalographic ambulatory recorder
No Description
LIFELINES LIMITED
Trackit 3 BT 24/0/B
In Commercial Distribution

  • 05060275450042 ()
1172

  • Electroencephalographic ambulatory recorder
No Description
LIFELINES LIMITED
Trackit 3 BT 32/0
In Commercial Distribution

  • 05060275450035 ()
1186

  • Electroencephalographic ambulatory recorder
No Description
LIFELINES LIMITED
Trackit 3 BT 18/8
In Commercial Distribution

  • 05060275450028 ()
1185

  • Electroencephalographic ambulatory recorder
No Description
LIFELINES LIMITED
Trackit 3 BT 20/4
In Commercial Distribution

  • 05060275450011 ()
1184

  • Electroencephalographic ambulatory recorder
No Description
LIFELINES LIMITED
Trackit 3 BT 24/0
In Commercial Distribution

  • 05060275450004 ()
1187

  • Electroencephalographic ambulatory recorder
Cervical Sleeve, 3mm Aperture
BIOSEAL
21080/05
In Commercial Distribution

  • 10630094210800 ()
  • 00630094210803 ()


  • Hygroscopic cervical dilator
Cervical Sleeve , 3mm Aperture
BIOSEAL
21060/05
In Commercial Distribution

  • 10630094210602 ()
  • 00630094210605 ()


  • Hygroscopic cervical dilator
Cervical Sleeve, 3mm Aperture
BIOSEAL
21040/10
In Commercial Distribution

  • 10630094210404 ()
  • 00630094210407 ()


  • Hygroscopic cervical dilator
Dilapan-S is a hygroscopic cervical dilator similar in shape to natural laminaria tents. It consists from the active part, made from the hydrophilic material (AQUACRYL 90), from the polypropylene handle, attached to the active part by the isocyanate adhesive, and from the polyamide signal string. Dilapan-S is capable of increasing in diameter as it absorbs moisture from the genital tract.
MEDICEM Technology s.r.o.
DS465
Not in Commercial Distribution

  • 08595231700062 ()
  • 08595231704657 ()
  • 08595231700055 ()

  • Length: 65 Millimeter
  • Outer Diameter: 4 Millimeter


  • Hygroscopic cervical dilator
Dilapan-S is a hygroscopic cervical dilator similar in shape to natural laminaria tents. It consists from the active part, made from the hydrophilic material (AQUACRYL 90), from the polypropylene handle, attached to the active part by the isocyanate adhesive, and from the polyamide signal string. Dilapan-S is capable of increasing in diameter as it absorbs moisture from the genital tract.
MEDICEM Technology s.r.o.
DS455
Not in Commercial Distribution

  • 08595231700048 ()
  • 08595231704558 ()
  • 08595231700031 ()

  • Length: 55 Millimeter
  • Outer Diameter: 4 Millimeter


  • Hygroscopic cervical dilator
Dilapan-S is a hygroscopic cervical dilator similar in shape to natural laminaria tents. It consists from the active part, made from the hydrophilic material (AQUACRYL 90), from the polypropylene handle, attached to the active part by the isocyanate adhesive, and from the polyamide signal string. Dilapan-S is capable of increasing in diameter as it absorbs moisture from the genital tract.
MEDICEM Technology s.r.o.
DS355
Not in Commercial Distribution

  • 08595231703551 ()
  • 08595231700024 ()
  • 08595231700017 ()

  • Outer Diameter: 3 Millimeter
  • Length: 55 Millimeter


  • Hygroscopic cervical dilator
Dilapan-S is a hygroscopic cervical dilator similar in shape to natural laminaria tents. It consists from the active part, made from the hydrophilic material (AQUACRYL 90), from the polypropylene handle, attached to the active part by the isocyanate adhesive, and from the polyamide signal string. Dilapan-S is capable of increasing in diameter as it absorbs moisture from the genital tract.
MEDICEM Technology s.r.o.
DS355
In Commercial Distribution

  • 08595231700291 ()
  • 08595231700284 ()
  • 08595231700307 ()
  • 08595231703094 ()
  • 08595231703100 ()

  • Outer Diameter: 3 Millimeter
  • Length: 55 Millimeter
3x55 mm

  • Hygroscopic cervical dilator
Dilapan-S is a hygroscopic cervical dilator similar in shape to natural laminaria tents. It consists from the active part, made from the hydrophilic material (AQUACRYL 90), from the polypropylene handle, attached to the active part by the isocyanate adhesive, and from the polyamide signal string. Dilapan-S is capable of increasing in diameter as it absorbs moisture from the genital tract.
MEDICEM Technology s.r.o.
DS455
In Commercial Distribution

  • 08595231700321 ()
  • 08595231700277 ()
  • 08595231700314 ()
  • 08595231703117 ()
  • 08595231703124 ()

  • Outer Diameter: 4 Millimeter
  • Length: 55 Millimeter
4x55 mm

  • Hygroscopic cervical dilator
Dilapan-S is a hygroscopic cervical dilator similar in shape to natural laminaria tents. It consists from the active part, made from the hydrophilic material (AQUACRYL 90), from the polypropylene handle, attached to the active part by the isocyanate adhesive, and from the polyamide signal string. Dilapan-S is capable of increasing in diameter as it absorbs moisture from the genital tract.
MEDICEM Technology s.r.o.
DS465
In Commercial Distribution

  • 08595231700345 ()
  • 08595231700260 ()
  • 08595231700338 ()
  • 08595231703131 ()
  • 08595231703148 ()

  • Outer Diameter: 4 Millimeter
  • Length: 65 Millimeter
4x65 mm

  • Hygroscopic cervical dilator
No Description
BIOSERENITY MEDICAL DEVICES GROUP
1001-10006-US
Not in Commercial Distribution

  • 03615220003990 ()


  • Electroencephalographic ambulatory recorder
No Description
BIOSERENITY MEDICAL DEVICES GROUP
1001-05001-UN
Not in Commercial Distribution

  • 03615220003983 ()


  • Electroencephalographic ambulatory recorder
No Description
BIOSERENITY MEDICAL DEVICES GROUP
1001-15023-UN
Not in Commercial Distribution

  • 03615220003679 ()


  • Electroencephalographic ambulatory recorder
No Description
BIOSERENITY MEDICAL DEVICES GROUP
1001-15022-UN
Not in Commercial Distribution

  • 03615220003662 ()


  • Electroencephalographic ambulatory recorder
No Description
BIOSERENITY MEDICAL DEVICES GROUP
1001-15021-UN
Not in Commercial Distribution

  • 03615220003655 ()


  • Electroencephalographic ambulatory recorder
Kit contents: One dilateria; thick (5mm), 2 gauze sponge envelops and IFU
Coopersurgical, Inc.
MX230
In Commercial Distribution

  • 60888937003323 ()
  • 00888937003321 ()

  • Outer Diameter: 5 Millimeter


  • Hygroscopic cervical dilator
Kit contents: One dilateria, medium (4mm); 2 gauze sponge envelopes and IFU
Coopersurgical, Inc.
MX220
In Commercial Distribution

  • 60888937003316 ()
  • 00888937003314 ()

  • Outer Diameter: 4 Millimeter


  • Hygroscopic cervical dilator
Kit contents: One dilateria, thin (3mm), 2 gauze sponge envelopes and IFU
Coopersurgical, Inc.
MX210
In Commercial Distribution

  • 60888937003309 ()
  • 00888937003307 ()

  • Outer Diameter: 3 Millimeter


  • Hygroscopic cervical dilator
No Description
GYNEX CORPORATION
16-105
In Commercial Distribution

  • GYNX161051 ()
  • GYNX16105 ()


  • Hygroscopic cervical dilator
No Description
GYNEX CORPORATION
16-104
In Commercial Distribution

  • GYNX161041 ()
  • GYNX161040 ()


  • Hygroscopic cervical dilator
No Description
GYNEX CORPORATION
16-103
In Commercial Distribution

  • GYNX161031 ()
  • GYNX161030 ()


  • Hygroscopic cervical dilator
Siesta 802 Basic EEG System w/o Software
Compumedics Usa, Inc.
Siesta 802 Basic EEG System
In Commercial Distribution

  • 09342451002112 ()
9007-0061-01

  • Electroencephalographic ambulatory recorder
Patient-interface for EEG ambulatory recorder
EB NEURO SPA
B8830073320
In Commercial Distribution

  • 08056446900956 ()


  • Electroencephalographic ambulatory recorder
Patient-interface for EEG ambulatory recorder
EB NEURO SPA
B8830073310
In Commercial Distribution

  • 08056446900949 ()


  • Electroencephalographic ambulatory recorder
Patient-interface for EEG ambulatory recorder
EB NEURO SPA
B9630073000
In Commercial Distribution

  • 08056446900055 ()


  • Electroencephalographic ambulatory recorder
Patient-interface for EEG ambulatory recorder
EB NEURO SPA
B9630073300
In Commercial Distribution

  • 08056446900048 ()


  • Electroencephalographic ambulatory recorder
USB interface for EEG ambulatory recorder
EB NEURO SPA
B8830073000
In Commercial Distribution

  • 08056446900024 ()


  • Electroencephalographic ambulatory recorder
EEG Long Term-Abulatory Recorder
EB NEURO SPA
B9700073000
In Commercial Distribution

  • 08056446900017 ()


  • Electroencephalographic ambulatory recorder
EEG Long Term-Abulatory System
EB NEURO SPA
B9800073000
In Commercial Distribution

  • 08056446900000 ()


  • Electroencephalographic ambulatory recorder
Dilator of Uterine Cervix
MEDGYN PRODUCTS, INC.
size 6 with buttons
In Commercial Distribution

  • M803021026 ()
021026

  • Hygroscopic cervical dilator
dilator of uterine cervix
MEDGYN PRODUCTS, INC.
size 5 with button
In Commercial Distribution

  • M803021025 ()
021025

  • Hygroscopic cervical dilator
Dilator of Uterine Cervix
MEDGYN PRODUCTS, INC.
size 4 with buttons
In Commercial Distribution

  • M803021024 ()
021024

  • Hygroscopic cervical dilator
Dilator of Uterine Cervix
MEDGYN PRODUCTS, INC.
size 3 with button
In Commercial Distribution

  • M803021023 ()
021023

  • Hygroscopic cervical dilator
Dilator of uterine cervix
MEDGYN PRODUCTS, INC.
size 2 with button
In Commercial Distribution

  • M803021022 ()
021022

  • Hygroscopic cervical dilator
Dilator of Uterine Cervix
MEDGYN PRODUCTS, INC.
size 8 long
In Commercial Distribution

  • M803021018 ()
021018

  • Hygroscopic cervical dilator
Dilator of Uterine Cervix
MEDGYN PRODUCTS, INC.
size 6 long
In Commercial Distribution

  • M803021016 ()
021016

  • Hygroscopic cervical dilator
Dilator of uterine cervix
MEDGYN PRODUCTS, INC.
size 5 long
In Commercial Distribution

  • M803021015 ()
021015

  • Hygroscopic cervical dilator
Dilator of Uterine Cervix
MEDGYN PRODUCTS, INC.
size 4 long
In Commercial Distribution

  • M803021014 ()
021014

  • Hygroscopic cervical dilator
Dilator of Uterine Cervix
MEDGYN PRODUCTS, INC.
size 10 Extra Jumbo
In Commercial Distribution

  • M803021010 ()
021010

  • Hygroscopic cervical dilator
Dilator of Uterine Cervix
MEDGYN PRODUCTS, INC.
size 8
In Commercial Distribution

  • M803021008 ()
021008

  • Hygroscopic cervical dilator
Dilator of uterine cervix
MEDGYN PRODUCTS, INC.
size 6
In Commercial Distribution

  • M803021006 ()
021006

  • Hygroscopic cervical dilator
Dilator of uterine cervix
MEDGYN PRODUCTS, INC.
size 5
In Commercial Distribution

  • M803021005 ()
021005

  • Hygroscopic cervical dilator
Dilator of uterine cervix
MEDGYN PRODUCTS, INC.
size 4
In Commercial Distribution

  • M803021004 ()
021004

  • Hygroscopic cervical dilator
Dilator of Uterine Cervix
MEDGYN PRODUCTS, INC.
size 3
In Commercial Distribution

  • M803021003 ()
021003

  • Hygroscopic cervical dilator
dilator of the uterine cervix
MEDGYN PRODUCTS, INC.
size 2
In Commercial Distribution

  • M803021002 ()
021002

  • Hygroscopic cervical dilator
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