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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Welch Allyn RETeval-DR Electroretinograph including Disposable Sensor Strips (2 Packs of 50 ea), Charging Dock, and USB Cable; Lithium-Ion Battery (#RETeval-ACC-02); 100-240 V, 50-60 Hz, IEC Plug Types A, G, E/F, and I; Multiple Languages
WELCH ALLYN, INC.
901101
In Commercial Distribution

  • 00732094214741 ()
RETEVAL-001

  • Ophthalmic fundus camera
Welch Allyn 3.5 V Halogen HPX Otoscope Set with Diagnostic Otoscope with Throat Illuminator (#20000), Rechargeable 60-Minute Power Handle(s) -- C-Cell Convertible, Hard Storage Case; Reusable Ear Specula (#24400-U); Nickel-Cadmium (#72300) Battery; IEC Plug Type-E/F
WELCH ALLYN, INC.
901079
Not in Commercial Distribution

  • 00732094083262 ()
25282

  • Otoscope, direct
120" Pediatric Expandable Circuit, Parallel WYE, 2() B/V Filters, Mini HEMF W/ CO2 Port, 1L not made with latex breathing bag, Sterile Yankuer, W/Bulb Tip, 10' x 0.050 M/M GSL, 10' Suction Tubing
WESTMED, INC.
9701
Not in Commercial Distribution

  • 10709078014526 ()
  • 00709078014529 ()


  • Anaesthesia breathing circuit, single-use
120" Adult 22mm/2mm Expandable Circuit, Parallel WYE, 2() B/V Filters, Mini HEMF W/ CO2 Port, Adult Vent Mask, 2L not made with latex breathing bag, Sterile Yankuer, W/Bulb Tip, 10' x 0.050 M/M GSL, 10' Suction Tubing
WESTMED, INC.
9700
Not in Commercial Distribution

  • 10709078014519 ()
  • 00709078014512 ()


  • Anaesthesia breathing circuit, single-use
Saljet is a single use disposable polymer vial with a twist off top containing 30ml of sterile normal saline 0.9% w/v. It contains no preservatives, surfactants or buffering. The vials are packed into a shelf carton. Twenty vials per carton.
WINCHESTER LABORATORIES LLLP
Saljet 20 HCL
In Commercial Distribution

  • 00188151000008 ()
  • 70188151000007 ()
  • 80188151000004 ()


  • Non-antimicrobial wound irrigation solution, saline
Saljet is a single use disposable polymer vial with a twist off top containing 30ml of sterile normal saline 0.9% w/v. It contains no preservatives, surfactants or buffering. The vials are packed into a shelf carton. Twenty vials per carton.
WINCHESTER LABORATORIES LLLP
Saljet 20
In Commercial Distribution

  • 60188151000000 ()
  • 50188151000003 ()
  • 00188151000015 ()


  • Non-antimicrobial wound irrigation solution, saline
No Description
EITAN MEDICAL LTD
12003-000-0024
In Commercial Distribution

  • 27290109159243 ()
  • 17290109159246 ()
12003-000-0024

  • Electric infusion pump administration set, single-use
Saljet 40 is a single use disposable polymer vial with a twist off top containing 30ml of sterile normal saline 0.9% w/v. It contains no preservatives, surfactants or buffering. The vials are packed into an outer shelf carton. Forty vials per carton.
WINCHESTER LABORATORIES LLLP
Saljet 40
In Commercial Distribution

  • 10188151000005 ()
  • 00188151000008 ()
  • 30188151000009 ()


  • Wound irrigation sterile saline
Saljet 6 is a single use disposable polymer vial with a twist off top containing 30ml of sterile normal saline 0.9% w/v. It contains no preservatives, surfactants or buffering. The vials are packed into an outer shelf carton. six vials per carton.
WINCHESTER LABORATORIES LLLP
Saljet 6
In Commercial Distribution

  • 20188151000002 ()
  • 00188151000008 ()
  • 40188151000006 ()


  • Wound irrigation sterile saline
The device consists of a sterile Screw Length Calibrator that includes reflective features that facilitate imaging of the (attached) instrument using instrument tracking technology when used with a compatible tracking system. The Screw Length Calibrator is utilized with the TrackX VISION™-V SNAP.
TrackX Technology, LLC
Screw Length Calibrator
Not in Commercial Distribution

  • 00857088008196 ()
300-3TX

  • Diagnostic x-ray digital imaging system workstation application software
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