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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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proSA® - 04041906139421

PROSA WITH MCLANAHAN RESERVOIR
Christoph Miethke GmbH & Co. KG
FV751T
Not in Commercial Distribution

  • 04041906139421 ()
FV751T

  • Cerebrospinal fluid shunt valve

proSA® - 04041906139384

PROSA WITH BURRHOLE RESERVOIR
Christoph Miethke GmbH & Co. KG
FV756T
Not in Commercial Distribution

  • 04041906139384 ()
FV756T

  • Cerebrospinal fluid shunt valve

proSA® - 04041906139346

PROSA WITH SPRUNG RESERVOIR
Christoph Miethke GmbH & Co. KG
FV746T
Not in Commercial Distribution

  • 04041906139346 ()
FV746T

  • Cerebrospinal fluid shunt valve

miniNAV® - 04041906139339

MININAV 15 WITH PRECHAMBER
Christoph Miethke GmbH & Co. KG
FV895T
In Commercial Distribution

  • 04041906139339 ()
FV895T

  • Cerebrospinal fluid shunt valve

miniNAV® - 04041906139322

MININAV 10 WITH PRECHAMBER
Christoph Miethke GmbH & Co. KG
FV894T
In Commercial Distribution

  • 04041906139322 ()
FV894T

  • Cerebrospinal fluid shunt valve

miniNAV® - 04041906139315

MININAV 5 WITH PRECHAMBER
Christoph Miethke GmbH & Co. KG
FV893T
In Commercial Distribution

  • 04041906139315 ()
FV893T

  • Cerebrospinal fluid shunt valve

miniNAV® - 04041906139308

MININAV 0 WITH PRECHAMBER
Christoph Miethke GmbH & Co. KG
FV892T
In Commercial Distribution

  • 04041906139308 ()
FV892T

  • Cerebrospinal fluid shunt valve

proSA® - 04041906138431

PROSA WITH PROGAV 2.0
Christoph Miethke GmbH & Co. KG
FX992T
In Commercial Distribution

  • 04041906138431 ()
FX992T

  • Cerebrospinal fluid shunt valve

proGAV 2.0® - 04041906137571

PROGAV 2.0 WITH PED.PRECHAMBER
Christoph Miethke GmbH & Co. KG
FX514T
Not in Commercial Distribution

  • 04041906137571 ()
FX514T

  • Cerebrospinal fluid shunt valve

proGAV 2.0® - 04041906137502

PROGAV 2.0 WITH PED.PRECHAMBER
Christoph Miethke GmbH & Co. KG
FX466T
In Commercial Distribution

  • 04041906137502 ()
FX466T

  • Cerebrospinal fluid shunt valve

miniNAV® - 04041906135515

MININAV 15 WITH PED.PRECHAMBER
Christoph Miethke GmbH & Co. KG
FV691T
In Commercial Distribution

  • 04041906135515 ()
FV691T

  • Cerebrospinal fluid shunt valve

miniNAV® - 04041906135485

MININAV 0 WITH PED.PRECHAMBER
Christoph Miethke GmbH & Co. KG
FV690T
In Commercial Distribution

  • 04041906135485 ()
FV690T

  • Cerebrospinal fluid shunt valve

Leg Extension - 10841962119426

Leg Extension with Cutout
Qfix
RT-5100-50-A-CO
In Commercial Distribution

  • 10841962119426 ()
RT-5100-50-A-CO

  • Patient lifting system stretcher

AESCULAP - 04038653464098

MONOPOLAR HANDLE WITH RATCHET
Aesculap AG
PO959R
In Commercial Distribution

  • 04038653464098 ()
PO959R

  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable

Millennium - 00190776298524

Cooley Retractor with teeth
Avalign Technologies, Inc.
1-508007
In Commercial Distribution

  • 00190776298524 ()


  • Surgical retractor/retraction system blade, reusable

Fortis ACP - 08800039802116

Cervical Awl, with Sleeve
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08800039802116 ()
TP.IN.0012

  • Bone awl, reusable

Hana ACP - 08800039800860

Cervical Awl, with Sleeve
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08800039800860 ()
UP.IN.0016

  • Bone awl, reusable

HME Flex - 10850014574793

HME with Flex Tube
PEPPER MEDICAL INC.
HME-712-Flex
In Commercial Distribution

  • 10850014574816 ()
  • 10850014574793 ()
HME-712-Flex

  • Heat/moisture exchanger, single-use

NA - 04042409041242

Handle with Dental Coupling
aap Implantate AG
IU 7602-00
In Commercial Distribution

  • 04042409041242 ()


  • Surgical instrument handle, non-torque-limiting

proGAV® - 04041906132132

PROGAV WITH SHUNTASSISTANT 35
Christoph Miethke GmbH & Co. KG
FV416T
Not in Commercial Distribution

  • 04041906132132 ()
FV416T

  • Cerebrospinal fluid shunt valve

proGAV® - 04041906132125

PROGAV WITH SHUNTASSISTANT 30
Christoph Miethke GmbH & Co. KG
FV415T
Not in Commercial Distribution

  • 04041906132125 ()
FV415T

  • Cerebrospinal fluid shunt valve

proGAV® - 04041906132118

PROGAV WITH SHUNTASSISTANT 25
Christoph Miethke GmbH & Co. KG
FV414T
Not in Commercial Distribution

  • 04041906132118 ()
FV414T

  • Cerebrospinal fluid shunt valve

proGAV® - 04041906132101

PROGAV WITH SHUNTASSISTANT 20
Christoph Miethke GmbH & Co. KG
FV413T
Not in Commercial Distribution

  • 04041906132101 ()
FV413T

  • Cerebrospinal fluid shunt valve

proGAV® - 04041906132095

PROGAV WITH SHUNTASSISTANT 15
Christoph Miethke GmbH & Co. KG
FV412T
Not in Commercial Distribution

  • 04041906132095 ()
FV412T

  • Cerebrospinal fluid shunt valve

proGAV® - 04041906132088

PROGAV WITH SHUNTASSISTANT 10
Christoph Miethke GmbH & Co. KG
FV411T
Not in Commercial Distribution

  • 04041906132088 ()
FV411T

  • Cerebrospinal fluid shunt valve

CONMED - 10845854041352

DRIVE SYSTEM WITH IRRIGATION
Conmed Corporation
D4000A
Not in Commercial Distribution

  • 30845854041356 ()
  • 10845854041352 ()
D4000A

  • Surgical power tool system control unit, line-powered

Kangaroo - 10884521619678

CO2 Detector with Bellows
Cardinal Health, Inc.
777702E
In Commercial Distribution

  • 10884521619678 ()
777702E

  • Exhaled-gas oesophageal intubation detector

Newport - 10884521544345

HT70 Ventilator with Accessories
Newport Medical Instruments, Inc.
HT70PM-RU-EU
Not in Commercial Distribution

  • 10884521544345 ()
HT70PM-RU-EU

  • Neonatal/adult intensive-care ventilator

Newport - 10884521543966

HT70 Ventilator with Accessories
Newport Medical Instruments, Inc.
HT70M-RU-EU
Not in Commercial Distribution

  • 10884521543966 ()
HT70M-RU-EU

  • Neonatal/adult intensive-care ventilator

Newport - 10884521543959

HT70 Ventilator with Accessories
Newport Medical Instruments, Inc.
HT70M-PT-BR
In Commercial Distribution

  • 10884521543959 ()


  • Neonatal/adult intensive-care ventilator

Newport - 10884521543942

HT70 Ventilator with Accessories
Newport Medical Instruments, Inc.
HT70M-JP-NA
Not in Commercial Distribution

  • 10884521543942 ()


  • Neonatal/adult intensive-care ventilator

Newport - 10884521543928

HT70 Ventilator with Accessories
Newport Medical Instruments, Inc.
HT70M-ES-NA
In Commercial Distribution

  • 10884521543928 ()


  • Neonatal/adult intensive-care ventilator

Newport - 10884521543911

HT70 Ventilator with Accessories
Newport Medical Instruments, Inc.
HT70M-ES-EU
In Commercial Distribution

  • 10884521543911 ()


  • Neonatal/adult intensive-care ventilator

MiniOX - 08688250002566

Oxygen Analyzer with Sensor
OHIO MEDICAL, LLC
MINIOX 1AS
Not in Commercial Distribution

  • 08688250002566 ()


  • Respiratory oxygen monitor, battery-powered

MiniOX - 08688250002559

Oxygen Monitor with Sensor
OHIO MEDICAL, LLC
MINIOX 3000S
Not in Commercial Distribution

  • 08688250002559 ()


  • Respiratory oxygen monitor, battery-powered

MiniOX - 08688250002542

Oxygen Analyzer with Sensor
OHIO MEDICAL, LLC
MINIOX 1S
Not in Commercial Distribution

  • 08688250002542 ()


  • Respiratory oxygen monitor, battery-powered

N/A - 00840239800398

Tray Lid - With Logo
ADVANCED RESEARCH MEDICAL LLC
00-L1
In Commercial Distribution

  • 00840239800398 ()
00-L1

  • Instrument tray, reusable

Innomed, Inc. - 00840277100467

Acetabular Pin with Stop
INNOMED, INC.
1200-03
In Commercial Distribution

  • 00840277100467 ()
1200-03

  • Orthopaedic inorganic implant inserter/extractor, reusable

EDENTA - E312174286540301

Hedstroem File with handle
EDENTA ETABLISSEMENT
174.28.654.030
In Commercial Distribution

  • E31217428654030101 ()
  • E312174286540301 ()


  • Manual endodontic file/rasp, reusable

EDENTA - E312174286540251

Hedstroem File with handle
EDENTA ETABLISSEMENT
174.28.654.025
In Commercial Distribution

  • E31217428654025101 ()
  • E312174286540251 ()


  • Manual endodontic file/rasp, reusable
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