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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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Faros 360 waterproof - 06430035220311

Device for 3-channel ECG and motion measurement, monitoring and data collection.
Bittium Biosignals Oy
Faros 360
In Commercial Distribution

  • 06430035220311 ()
901159

  • Telemetric electrocardiographic ambulatory recorder

Orthex - 00841731119209

Orthex P&C Software
VILEX IN TENNESSEE, INC.
ORTHEXRPS
Not in Commercial Distribution

  • 00841731119209 ()


  • External orthopaedic fixation frame calculation software

Orthex - 00841731118844

Orthex P&C Software v1.2
VILEX IN TENNESSEE, INC.
ORTHEXRPS
In Commercial Distribution

  • 00841731118844 ()


  • External orthopaedic fixation frame calculation software

MAXFRAME - 10886982346896

MAXFRAME AUTOSTRUT (TM) SOFTWARE
Synthes GmbH
03.312.003
In Commercial Distribution

  • 10886982346896 ()
03312003

  • External orthopaedic fixation frame calculation software

MAXFRAME - 10886982340832

MAXFRAME AUTOSTRUT(TM) SOFTWARE
SYNTHES (U.S.A.) LP
1110005-01
In Commercial Distribution

  • 10886982340832 ()
111000501

  • External orthopaedic fixation frame calculation software

MAXFRAME - 10886982260949

MAXFRAME(TM) SOFTWARE
SYNTHES (U.S.A.) LP
03.312.000
In Commercial Distribution

  • 07612334140258 ()
  • H679033120000 ()
  • 10886982260949 ()
03312000

  • External orthopaedic fixation frame calculation software

AURA - G460DG1010

AURA™ Data Receiver Pack
Branchpoint & Aura Development LLC
DG101
Not in Commercial Distribution

  • G460DG1010 ()


  • Medical networking interface unit

Orthex - 00841132179772

Orthex P&C Software v1.2
ORTHOPEDIATRICS CORP.
ORTHEXRPS
In Commercial Distribution

  • 00841132179772 ()
ORTHEXRPS

  • External orthopaedic fixation frame calculation software

Orthex/ Instrument Case - 00841132178799

Rail Tray - Dual Track Rail Caddy
ORTHOPEDIATRICS CORP.
01-2200-0105
In Commercial Distribution

  • 00841132178799 ()
01-2200-0105

  • External orthopaedic fixation frame calculation software

Orthex/ Instrument Case - 00841132178775

Rail Tray - Wire Caddy
ORTHOPEDIATRICS CORP.
01-2200-0104
In Commercial Distribution

  • 00841132178775 ()
01-2200-0104

  • External orthopaedic fixation frame calculation software
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