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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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SNAPLIGHT SET:GREEN SPEC HAND + MAC 2,3,4+MILL 1
TELEFLEX INCORPORATED
IPN915514
In Commercial Distribution

  • 54026704711944 ()
  • 14026704711946 ()
  • 24026704711943 ()
4273/X

  • Rigid optical laryngopharyngoscope
SNAPLIGHT SET:GREEN SPEC HAND+ MAC 2,3,4 +MILL 0
TELEFLEX INCORPORATED
IPN915513
In Commercial Distribution

  • 54026704711937 ()
  • 14026704711939 ()
  • 24026704711936 ()
4272/X

  • Rigid optical laryngopharyngoscope
SNAPLIGHT SET:GREEN SPEC HANDLE + MILL 00,1,2,3
TELEFLEX INCORPORATED
IPN915511
In Commercial Distribution

  • 54026704711913 ()
  • 14026704711915 ()
  • 24026704711912 ()
4263/X

  • Rigid optical laryngopharyngoscope
SNAPLIGHT SET:GREEN SPEC HANDLE + MAC 2,3,4
TELEFLEX INCORPORATED
IPN915510
In Commercial Distribution

  • 54026704711906 ()
  • 14026704711908 ()
  • 24026704711905 ()
4262/X

  • Rigid optical laryngopharyngoscope
SNAPLIGHT SET: GREEN SPEC HANDLE + MAC 1,2,3,4
TELEFLEX INCORPORATED
IPN915508
In Commercial Distribution

  • 54026704711883 ()
  • 14026704711885 ()
  • 24026704711882 ()
4261/X

  • Rigid optical laryngopharyngoscope
SCS COR'L CAST RT SUB MIN
Bausch & Lomb Incorporated
E3304 X
In Commercial Distribution

  • 00757770420605 ()
E3304 X

  • Corneal scissors, reusable
Package of 5 single-use tips for the LITETOUCH system
LIGHT INSTRUMENTS LTD
ENDO
In Commercial Distribution

  • 07290016784060 ()
  • 37290016784061 ()
LI-FG4001(X)

  • Dental solid-state laser system
Base (station)
LIGHT INSTRUMENTS LTD
1
In Commercial Distribution

  • 07290016784046 ()
LI-FGD002(X)

  • Dental solid-state laser system
Diode (portable)
LIGHT INSTRUMENTS LTD
1
In Commercial Distribution

  • 07290016784039 ()
LI-FGD001(X)

  • Dental solid-state laser system
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
SCS COR'L SEC CAST LT SUB MINI
Bausch & Lomb Incorporated
E3305 X
In Commercial Distribution

  • 00757770404353 ()
E3305 X

  • Corneal scissors, reusable
EchoBed X, H-F, No Drop
MEDICAL POSITIONING, INC.
022
In Commercial Distribution

  • 00848871001456 ()


  • Multi-purpose diagnostic imaging table
EchoBed X, H-F-T, 2D
MEDICAL POSITIONING, INC.
233
In Commercial Distribution

  • 00848871001036 ()


  • Multi-purpose diagnostic imaging table
EchoBed X, H-T, 2D
MEDICAL POSITIONING, INC.
223
In Commercial Distribution

  • 00848871000992 ()


  • Multi-purpose diagnostic imaging table
EchoBed X, H-F, 2D
MEDICAL POSITIONING, INC.
222
In Commercial Distribution

  • 00848871000954 ()


  • Multi-purpose diagnostic imaging table
EchoBed X, H, 2D
MEDICAL POSITIONING, INC.
201
In Commercial Distribution

  • 00848871000916 ()


  • Multi-purpose diagnostic imaging table
No Description
NAKANISHI INC.
X-SG65
In Commercial Distribution

  • 04560264560673 ()
  • 04560264557314 ()


  • Dental surgical power tool motorized handpiece/set, electric
MinerOss X Cancellous Particl 1000um-2000um, 1.0g/2.2cc
ACE SURGICAL SUPPLY CO., INC.
BH0028
Not in Commercial Distribution

  • 00614950025688 ()

  • Weight: 1 Gram
BH0028

  • Dental bone matrix implant, animal-derived
MinerOss X Cancellous Particl Size 1000um-2000um, 0.25g/0.6cc
ACE SURGICAL SUPPLY CO., INC.
BH0027
Not in Commercial Distribution

  • 00614950025671 ()

  • Weight: 0.25 Gram
BH0027

  • Dental bone matrix implant, animal-derived
MinerOss X Cancellous Particl Size 1000um-2000um, 2.0g/4.4cc
ACE SURGICAL SUPPLY CO., INC.
BH0026
Not in Commercial Distribution

  • 00614950025435 ()

  • Weight: 2 Gram
BH0026

  • Dental bone matrix implant, animal-derived
MinerOss X Cancellous Particl Size 1000um-2000um, 0.5g/1.1cc
ACE SURGICAL SUPPLY CO., INC.
BH0025
Not in Commercial Distribution

  • 00614950025428 ()

  • Weight: 0.5 Gram
BH0025

  • Dental bone matrix implant, animal-derived
X SERIES, MONITOR/DEFIBRILLATOR, 12 LD W/ INTERP, ECG, NIBP, SPO2, DMST, REFURB
Zoll Medical Corporation
601-2120010-01-66
In Commercial Distribution

  • 00847946060718 ()


  • Rechargeable professional automated external defibrillator
X SERIES, MONITOR/DEFIBRILLATOR, 12 LD W/ INTERP, ECG, NIBP, SPO2, DMST
Zoll Medical Corporation
601-2120010-01
In Commercial Distribution

  • 00847946060701 ()


  • Rechargeable professional automated external defibrillator
X SERIES, MONITOR/DEFIBRILLATOR, 12 LD W/ INTERP, ECG, SPO2, CPR EXPANSION, US
Zoll Medical Corporation
601-2120001-01
In Commercial Distribution

  • 00847946060688 ()


  • Rechargeable professional automated external defibrillator
X SERIES, X SERIES MONITOR/DEFIBRILLATOR 12 LEAD/W INTERP, CPR, DMST
Zoll Medical Corporation
601-2100001-01
In Commercial Distribution

  • 00847946060671 ()


  • Rechargeable professional automated external defibrillator
X SERIES, X SERIES MONITOR/DEFIBRILLATOR 12 LEAD/W INTERP, DMST
Zoll Medical Corporation
601-2100000-01
In Commercial Distribution

  • 00847946060664 ()


  • Rechargeable professional automated external defibrillator
X Series, 12 LD, ALS, PACE, SPO2, CO2, NIBP, IBP/TEMP, CPR EXTENDED, DMST, REFURB
Zoll Medical Corporation
601-1221511-01-66
In Commercial Distribution

  • 00847946060657 ()


  • Rechargeable professional automated external defibrillator
X Series, 12 LD, ALS, PACE, SPO2, CO2, NIBP, IBP/TEMP, CPR EXTENDED, DMST
Zoll Medical Corporation
601-1221511-01
In Commercial Distribution

  • 00847946060640 ()


  • Rechargeable professional automated external defibrillator
X SERIES, MONITOR/DEFIBRILLATOR, 3/5 LEAD, PACE, VOICE, ETCO2, NIBP, SPO2, CPR EXPANSION PACK, DMST
Zoll Medical Corporation
601-0421011-01
In Commercial Distribution

  • 00847946060619 ()


  • Rechargeable professional automated external defibrillator
X SERIES, MONITOR/DEFIBRILLATOR, 3/5 LEAD, PACE, VOICE, NIBP, SPO2, CPR EXPANSION PACK, DMST
Zoll Medical Corporation
601-0420011-01
In Commercial Distribution

  • 00847946060602 ()


  • Rechargeable professional automated external defibrillator
X SERIES, MONITOR/DEFIBRILLATOR, 3/5 LEAD, PACE, VOICE, SPO2, CPR EXPANSION PACK
Zoll Medical Corporation
601-0420001-01
In Commercial Distribution

  • 00847946060596 ()


  • Rechargeable professional automated external defibrillator
X SERIES MONITOR/DEFIBRILLATOR 3/5 LEAD, PACING, NIBP, SPO2, SPCO, SPMET, IBP/TEMP CPR EXPANSION PACK AND ETCO2, DMST, REFURB
Zoll Medical Corporation
601-0241511-01-66
In Commercial Distribution

  • 00847946060565 ()


  • Rechargeable professional automated external defibrillator
X SERIES MONITOR/DEFIBRILLATOR 3/5 LEAD, PACING, NIBP, SPO2, SPCO, SPMET, IBP/TEMP CPR EXPANSION PACK AND ETCO2, DMST
Zoll Medical Corporation
601-0241511-01
In Commercial Distribution

  • 00847946060558 ()


  • Rechargeable professional automated external defibrillator
X SERIES, MONITOR/DEFIBRILLATOR, 3/5 LEAD, ECG, PACING, NIBP, SPO2, SPCO, SPMET, CPR EXPANSION PACK, ETCO2, DMST, REFURB
Zoll Medical Corporation
601-0241011-01-66
In Commercial Distribution

  • 00847946060510 ()


  • Rechargeable professional automated external defibrillator
X SERIES, MONITOR/DEFIBRILLATOR, 3/5 LEAD, ECG, PACING, NIBP, SPO2, SPCO, SPMET, CPR EXPANSION PACK, ETCO2, DMST
Zoll Medical Corporation
601-0241011-01
In Commercial Distribution

  • 00847946060503 ()


  • Rechargeable professional automated external defibrillator
X SERIES, MONITOR/DEFIBRILLATOR, 3/5 LEAD, ECG, PACING, NIBP, SPO2, SPCO, SPMET, ETCO2, DMST, REFURB
Zoll Medical Corporation
601-0241010-01-66
In Commercial Distribution

  • 00847946060497 ()


  • Rechargeable professional automated external defibrillator
X SERIES, MONITOR/DEFIBRILLATOR, 3/5 LEAD, ECG, PACING, NIBP, SPO2, SPCO, SPMET, ETCO2, DMST
Zoll Medical Corporation
601-0241010-01
In Commercial Distribution

  • 00847946060480 ()


  • Rechargeable professional automated external defibrillator
X SERIES, MONITOR/DEFIBRILLATOR, 3/5 LEAD, ECG, PACING, NIBP, SPO2, SPCO, SPMET, IBP/TEMP, CPR EXPANSION PACK, DMST
Zoll Medical Corporation
601-0240511-01
In Commercial Distribution

  • 00847946060473 ()


  • Rechargeable professional automated external defibrillator
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