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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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proGAV® - 04041906132088

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

  • 04041906132088 ()
FV411T

  • Cerebrospinal fluid shunt valve

proGAV 2.0® - 04041906140540

PROGAV 2.0 WITH PED.PRECHAMBER
Christoph Miethke GmbH & Co. KG
FX314T
Not in Commercial Distribution

  • 04041906140540 ()
FX314T

  • Cerebrospinal fluid shunt valve

proGAV 2.0® - 04041906140472

PROGAV 2.0 WITH PRECHAMBER
Christoph Miethke GmbH & Co. KG
FX335T
Not in Commercial Distribution

  • 04041906140472 ()
FX335T

  • Cerebrospinal fluid shunt valve

proGAV 2.0® - 04041906140403

PROGAV 2.0 WITH PRECHAMBER
Christoph Miethke GmbH & Co. KG
FX363T
In Commercial Distribution

  • 04041906140403 ()
FX363T

  • Cerebrospinal fluid shunt valve

proSA® - 04041906139582

PROSA WITH PED.BURRHOLE RESERVOIR
Christoph Miethke GmbH & Co. KG
FV736T
Not in Commercial Distribution

  • 04041906139582 ()
FV736T

  • Cerebrospinal fluid shunt valve

proSA® - 04041906139506

PROSA WITH CONTROL RESERVOIR
Christoph Miethke GmbH & Co. KG
FV731T
Not in Commercial Distribution

  • 04041906139506 ()
FV731T

  • Cerebrospinal fluid shunt valve

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

CONMED - 10845854045527

IFS CART WITH VALVE
Conmed Corporation
AS-ICART-V
In Commercial Distribution

  • 20845854045524 ()
  • 10845854045527 ()
AS-ICART-V

  • Electromechanical device/system transport trolley

MILLENNIUM - 00190776342524

Percussion Awl with metal
Avalign Technologies, Inc.
35-64416005
In Commercial Distribution

  • 00190776342524 ()


  • Bone awl, 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

CONMED - 10845854041352

DRIVE SYSTEM WITH IRRIGATION
Conmed Corporation
D4000A
Not in Commercial Distribution

  • 30845854041356 ()
  • 10845854041352 ()
D4000A

  • Surgical power tool system control unit, line-powered

Millennium - 00190776365011

Suction Tip, With Holes,
Avalign Technologies, Inc.
17-147005
In Commercial Distribution

  • 00190776365011 ()


  • Surgical/emergency suction cannula, non-illuminating, reusable

AESCULAP - 04038653471720

MINITRAY WITH LID 145X44X25MM
Aesculap AG
JF148R
In Commercial Distribution

  • 04038653471720 ()
JF148R

  • Surgical instrument/implant rack

ZEUS-L - 00840916158590

LLIF SHIM WITH STOP
SPINAL ELEMENTS
SP-0462
Not in Commercial Distribution

  • 00840916158590 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable

ZEUS-L - 00840916158538

BRAINLAB SLEEVE WITH BAYONET
SPINAL ELEMENTS
SP-0275
Not in Commercial Distribution

  • 00840916158538 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable

ZEUS-C - 00840916160043

ZEUS-C INSERTER WITH STOPS
SPINAL ELEMENTS
SP-0549
In Commercial Distribution

  • 00840916160043 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable

ZEUS-C - 00840916160036

ZEUS-C TAMP WITH STOPS
SPINAL ELEMENTS
SP-0538
In Commercial Distribution

  • 00840916160036 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable

Perifit - 03770014642660

Kegel Exerciser with App
X6 INNOVATIONS
Green Perifit
In Commercial Distribution

  • 03770014642660 ()


  • Pelvic floor muscle exerciser

Perifit - 03770014642448

Kegel Exerciser with App
X6 INNOVATIONS
Pink Perifit
In Commercial Distribution

  • 03770014642448 ()


  • Pelvic floor muscle exerciser

Perifit Care+ - 03770014642196

Kegel Exerciser with App
X6 INNOVATIONS
Purple Perifit Care+
In Commercial Distribution

  • 03770014642196 ()


  • Pelvic floor muscle exerciser

Perifit Care - 03770014642165

Kegel Exerciser with App
X6 INNOVATIONS
Green Perifit Care
In Commercial Distribution

  • 03770014642165 ()


  • Pelvic floor muscle exerciser

Perifit Care - 03770014642134

Kegel Exerciser with App
X6 INNOVATIONS
Pink Perifit Care
In Commercial Distribution

  • 03770014642134 ()


  • Pelvic floor muscle exerciser

Rasp - 03760418040209

Rasp with titanium handle
SC MEDICA
57.003.00T
In Commercial Distribution

  • 03760418040209 ()


  • Orthopaedic osteotome

Vaginal CT/MR Multi Channel Applicator - 08717213053724

Catheter with collar 6Fx293
Nucletron B.V.
110802-01
In Commercial Distribution

  • 08717213054356 ()
  • 08717213053724 ()

  • Catheter Gauge: 6.0 French
  • Length: 293.0 Millimeter


  • Cervical/intrauterine brachytherapy system applicator, remote-afterloading

Starrsed - 08719189137774

Low profile with inserts
Mechatronics USA LLC
A0026376
In Commercial Distribution

  • 08719189137774 ()


  • Erthrocyte sedimentation rate (ESR) analyser IVD

Starrsed - 08719189137767

Low profile with inserts
Mechatronics USA LLC
A0026376
In Commercial Distribution

  • 08719189137767 ()


  • Erthrocyte sedimentation rate (ESR) analyser IVD

BacterioScan 216Dx System - B9090052

Case with 256 cartridges.
BACTERIOSCAN, INC.
Clear Cartridge - 4 Well Case
In Commercial Distribution

  • B90900522 ()
  • B9090052 ()


  • Microbial incubator/imaging system IVD

Therabody - 00840295403342

Sleeping Mask with vibration
Therabody, Inc.
Sleep Mask
In Commercial Distribution

  • 00840295403342 ()


  • Hand-held electric massager

N.A. - EFOR50108071

Distalcutter medium with safety-hold
Forestadent Bernhard Förster GmbH
-501-0807
In Commercial Distribution

  • EFOR50108071 ()


  • Orthodontic pliers

N.A. - EFOR50108061

Distalcutter maxi with safety-hold
Forestadent Bernhard Förster GmbH
-501-0806
In Commercial Distribution

  • EFOR50108061 ()


  • Orthodontic pliers

N.A. - EFOR50108051

Distalcutter mini with safety-hold
Forestadent Bernhard Förster GmbH
-501-0805
In Commercial Distribution

  • EFOR50108051 ()


  • Orthodontic pliers

Bone Access Kit - B875TRAPLID0

Convenience kit with Lidocaine
Custom Interventional Pain Management, LLC
TRAP
In Commercial Distribution

  • B875TRAPLID0 ()
TRAP

  • Bone marrow biopsy procedure kit

Discseel - B875DSCLID0

Convenience kit with Lidocaine
Custom Interventional Pain Management, LLC
DSCLID
In Commercial Distribution

  • B875DSCLID0 ()
DSCLID

  • Intrathecal anaesthesia set, medicated

Bone Access Kit - B875CTDLID0

Convenience kit with Lidocaine
Custom Interventional Pain Management, LLC
CTDLID
In Commercial Distribution

  • B875CTDLID0 ()
CTDLID

  • Bone marrow biopsy procedure kit

Discseel - B87560LID0

Convenience kit with Lidocaine
Custom Interventional Pain Management, LLC
60LID
In Commercial Distribution

  • B87560LID0 ()
60LID

  • Intrathecal anaesthesia set, medicated

Spinal Anesthesia Kit - B87541LID0

Convenience kit with Lidocaine
Custom Interventional Pain Management, LLC
41LID
In Commercial Distribution

  • B87541LID0 ()
41LID

  • Epidural anaesthesia set, medicated

Custom Anesthesia Tray - B87531LID0

Convenience kit with Lidocaine
Custom Interventional Pain Management, LLC
31LID
In Commercial Distribution

  • B87531LID0 ()
31LID

  • Epidural anaesthesia set, medicated

Epidural Anesthesia Kit - B87522LID0

Convenience kit with Lidocaine
Custom Interventional Pain Management, LLC
22LID
In Commercial Distribution

  • B87522LID0 ()
22LID

  • Epidural anaesthesia set, medicated

Epidural Anesthesia Kit - B87520LID0

Convenience kit with Lidocaine
Custom Interventional Pain Management, LLC
20LID
In Commercial Distribution

  • B87520LID0 ()
20LID

  • Epidural anaesthesia set, medicated

Epidural Anesthesia Kit - B87518LID0

Convenience kit with Lidocaine
Custom Interventional Pain Management, LLC
18LID
In Commercial Distribution

  • B87518LID0 ()
18LID

  • Epidural anaesthesia set, medicated

Epidural Anesthesia Kit - B87517LID0

Convenience kit with Lidocaine
Custom Interventional Pain Management, LLC
17LID
In Commercial Distribution

  • B87517LID0 ()
17LID

  • Epidural anaesthesia set, medicated

Vaginal CT/MR Multi Channel Applicator - 08717213022492

Catheter with collar 6Fx293
Nucletron B.V.
110802-00
In Commercial Distribution

  • 08717213022423 ()
  • 08717213022492 ()

  • Catheter Gauge: 6.0 French
  • Device Size Text, specify:
  • Length: 293.0 Millimeter


  • Cervical/intrauterine brachytherapy system applicator, remote-afterloading
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