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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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tetraONE
Beckman Coulter, Inc.
6915050
In Commercial Distribution

  • 15099590572679 ()
6915050

  • Laboratory instrument/analyser application software IVD
stemONE
Beckman Coulter, Inc.
6915452
In Commercial Distribution

  • 15099590559519 ()
6915452

  • Laboratory instrument/analyser application software IVD
moorVMS-PC Software V4.0 is a Windows based software package designed to work with the moorVMS setup and is fully compatible with all of the existing modules.
MOOR INSTRUMENTS LIMITED
4
In Commercial Distribution

  • 15060484490096 ()


  • Tissue saturation oximeter
  • Laser Doppler blood flowmeter
Proprietary bio-compatible patch electrode array with nine Ag/AgCl pads lined with hydrogel. Intended to be used with TrueLabor Maternal Unit.
O.B - TOOLS LTD
FG0003(X)
Not in Commercial Distribution

  • 07290016406030 ()
  • 17290016406037 ()
  • 27290016406034 ()

  • Width: 280 Millimeter
  • Length: 320 Millimeter
FG0003(X)

  • Cardiotocography telemetric monitoring system
The TrueLabor's Monitor Adapter for the hospital maternal/fetal monitoring system. The corresponding Maternal Unit transmits the uterine activity/fetal heart rate information via Bluetooth to the MONITOR ADAPTER which transfers it to the hospital monitor or directly to the hospital IT system.
O.B - TOOLS LTD
FG0002(X)
In Commercial Distribution

  • 07290016406023 ()

  • Depth: 30 Millimeter
  • Width: 200 Millimeter
  • Height: 120 Millimeter
  • Weight: 400 Gram
FG0002(X)

  • Cardiotocography telemetric monitoring system
TrueLabor's Maternal Unit is connected via a proprietary connector to the Embrace electrode array. The MU acquires EMG signals and provides Fetal Heart Rate and Uterine Activity are transmitted via Bluetooth. The unit contains a Li-Ion rechargeable battery.
O.B - TOOLS LTD
FG0001(X)
In Commercial Distribution

  • 07290016406016 ()

  • Width: 90 Millimeter
  • Height: 125 Millimeter
  • Depth: 29 Millimeter
  • Weight: 240 Gram
FG0001(X)

  • Cardiotocography telemetric monitoring system
TAPES primary packaging (x1)
Endo Tools Therapeutics
TAPES
In Commercial Distribution

  • 05425029282698 ()
  • 05425029282094 ()
  • 05425029282391 ()
  • 05425029282995 ()
  • 05425029282919 ()
  • 05425029282988 ()
  • 05425029282933 ()
  • 05425029282964 ()


  • Suturing unit, single-use
endomina system is composed of 1 endomina platform and 6 TAPES
Endo Tools Therapeutics
endomina system
In Commercial Distribution

  • 05425029282070 ()
  • 05425029282971 ()


  • Endoscopic overtube, single-use
  • Suturing unit, single-use
endomina platform primary packaging (x1)
Endo Tools Therapeutics
endomina platform
In Commercial Distribution

  • 05425029282117 ()
  • 05425029282018 ()
  • 05425029282339 ()
  • 05425029282940 ()
  • 05425029282957 ()
  • 05425029282926 ()


  • Endoscopic overtube, single-use
ZephyrLIFE Hospital Application Software Application?
ZEPHYR TECHNOLOGY LLC
Software Hospital
Not in Commercial Distribution

  • 10884521712904 ()
Software Hospital

  • Electrosurgical return electrode, single-use
ZephyrLIFE Home HealthHub Patient Software Application?
ZEPHYR TECHNOLOGY LLC
Software Home
Not in Commercial Distribution

  • 10884521712898 ()
Software Home

  • Electrosurgical return electrode, single-use
SOFTWARE GE CLIENT SOFTWARE V6.9.6 R3
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
v6.9.6 R3
Not in Commercial Distribution

  • 00840682123532 ()


  • Cardiac catheterization monitoring system
  • Cardiac electrophysiology analysis system
hi-PS (Programming Software) Fitting Software, Solo
INTRICON CORPORATION
hi-PS Solo
In Commercial Distribution

  • 00858177007151 ()
23126

  • Hearing aid wireless-fitting computer-aided set
Software, Opal Acquire Image Acquisition Software.
KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.
OPALACQ-02-04-00-000
In Commercial Distribution

  • 00817100020438 ()


  • Diagnostic x-ray digital imaging system workstation application software
Software, Opal Acquire Image Acquisition Software
KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.
OPALACQ-02-03-04-000
In Commercial Distribution

  • 00817100020421 ()


  • Diagnostic x-ray digital imaging system workstation application software
Software, Opal Acquire Image Acquisition Software.
KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.
OPALACQ-04-01-00-000
In Commercial Distribution

  • 00817100020414 ()


  • Diagnostic x-ray digital imaging system workstation application software
Software, Opal Acquire Image Acquisition Software.
KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.
OPALACQ 04-02-01-000
In Commercial Distribution

  • 00817100020186 ()


  • Diagnostic x-ray digital imaging system workstation application software
No Description
OLYMPUS MEDICAL SYSTEMS CORP.
MAJ-2039
Not in Commercial Distribution

  • 04953170360824 ()
N5368940

  • Video capsule endoscopy system application software
Orientation Lead Clip Holder Spanner Parts
DENTIN IMPLANTS TECHNOLOGIES LTD
OLCH-2200
In Commercial Distribution

  • 07290113354104 ()


  • Surgical screwdriver, reusable
Hand tissue punch
DENTIN IMPLANTS TECHNOLOGIES LTD
DCT-0850
In Commercial Distribution

  • 07290113356313 ()


  • Dental soft-tissue coring punch, reusable
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