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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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Auto Tono/Refracto/Kerato/Pachymeter HTR-1A
Huvitz Co., Ltd.
HTR-1A
In Commercial Distribution

  • 08800019600558 ()
HTR-1A

  • Ophthalmic tonometer, battery-operated
  • Automated ophthalmic refractometer
  • Bench-top keratometer
The CrossRoads™ Screw System is indicated for fracture repair and fixation, osteotomy, joint fusion, reconstruction and arthrodesis of bones appropriate for the size of the device.
CROSSROADS EXTREMITY SYSTEMS
15LP-3546
In Commercial Distribution

  • 00815432028887 ()
15LP-3546

  • Surgical depth gauge, single-use
  • Surgical screwdriver, single-use
  • Fluted surgical drill bit, single-use
  • Orthopaedic bone wire
  • Surgical instrument handle, non-torque-limiting
  • Surgical countersink, single-use
Surveyor S12 GEN2 Patient Monitoring System - Surveyor Sp02, ECG, Dual Temp, NIBP, No IBP, resistive color touchscreen 11.6 in. display with 1366 x 768 resolution, AC or lithium ion rechargeable battery operation; International power cord; IEC 5 wire ECG patient cable with clip ends; Edwards invasive blood pressure cable (qty 2) and Y cable; No cardiac output cable; No printer; LAN+WLAN; No mounting options
WELCH ALLYN, INC.
901138
In Commercial Distribution

  • 00732094261707 ()
SUR12-TDD-DXXBX

  • Multiple-patient intensive/general healthcare physiologic monitoring system
AUTO REF/KERATO/TONOMETER Model TONOREF II is designed to singly perform objective refraction, corneal shape measurement, and non-contact tonometry measurement by incorporating a standard auto ref/keratometer and non-contact tonometer into one unit. The objective refraction function measures spherical powers, cylindrical powers and cylinder axis. The corneal shape measurement function measures the radius of corneal curvature (corneal refractive powers), the direction of the steepest meridian, and the amount of corneal astigmatism. The non-contact tonometry function measures the intraocular pressure without contacting the eye.
NIDEK CO.,LTD.
TONOREF II
In Commercial Distribution

  • 04987669100066 ()


  • Ophthalmic tonometer, line-powered
  • Bench-top keratometer
  • Automated ophthalmic refractometer
No Description
ARTHREX, INC.
CRx DISPOSABLE INTRUMENTS PACKAGE
Not in Commercial Distribution

  • 00816988011446 ()
ST0101_A

  • Surgical drill guide, single-use
  • Orthopaedic bone wire
  • Cannulated surgical drill bit, single-use
RENASYS TOUCH CONNECT Pump provides negative pressure therapy to a wound at a range of pressure settings via a tube set connected to a wound dressing. Pressure setting deliver setup is selectable via LCD screen. The suction pump creates negative pressure and removes exudate from the wound site to a disposable canister. The device can operate by either an external mains power supply or internal battery. The RENASYS TOUCH CONNECT pump has the facility to connect wirelessly to a cloud based system. Several accessories are available for use with the Pump including Canisters, Power supply either Class I or II, Carry Bag, Carry Strap and IV Pole/Bed Clamp. The Pump is suitable for use in both hospital and homecare settings. The Pump is compatible with existing Smith & Nephew Negative Pressure wound dressing kits on the market.
SMITH & NEPHEW MEDICAL LIMITED
66801791
In Commercial Distribution

  • 05000223490782 ()
66801791

  • Negative-pressure wound therapy system, battery-powered, reusable
Surveyor S12 GEN2 Patient Monitoring System - Nellcor Sp02, ECG, Dual Temp, NIBP, IBP 1/2, CO2, starter kit, resistive color touchscreen 11.6 in. display with 1366 x 768 resolution, AC or lithium ion rechargeable battery operation; International power cord; IEC 3 wire ECG patient cable with clip ends; Edwards invasive blood pressure cable (qty 2) and Y cable; No cardiac output cable; No printer; LAN+WLAN; No mounting options
WELCH ALLYN, INC.
901138
In Commercial Distribution

  • 00732094261721 ()
SUR12-SDB-DXXBX

  • Multiple-patient intensive/general healthcare physiologic monitoring system
Surveyor S19 GEN2 Patient Monitoring System - Nellcor Sp02, ECG, Dual Temp, NIBP, IBP 1/2, resistive color touchscreen 18.5 in. display with 1366 x 768 resolution, AC or lithium ion rechargeable battery operation; International power cord; AM12 Wired Acquisition Module with AHA 12-lead lead set with snap ends and 1 IEC 5 wire ECG patient cable with clip ends; Edwards invasive blood pressure cable; No cardiac output cable; No printer; LAN; No mounting options
WELCH ALLYN, INC.
901138
In Commercial Distribution

  • 00732094261585 ()
SUR19-LDH-BXXAX

  • Multiple-patient intensive/general healthcare physiologic monitoring system
A device that scans photostimulable phosphor plates that have been exposed in the place of dental x-ray film and allows those images to be displayed on a CRT and stored for later recovery in a computer memory. It will be used by dentists and authorized dental auxiliary personnel for this purpose. This kit contains an installation disc, USB cable and power supply, PSPs, barrier envelopes, barrier film rolls, PSP wipes, and a scanner cleaning sheet.
AIR TECHNIQUES, INC.
G8010
In Commercial Distribution

  • D678G80001 ()
  • D678G80100 ()
  • D678G80101 ()

  • Weight: 14.5 Pound
  • Outer Diameter: 9.6 Inch
  • Height: 9.2 Inch
  • Width: 8.9 Inch


  • Radiography digital imaging scanner
Surveyor S12 GEN2 Patient Monitoring System - Surveyor Sp02, ECG, Dual Temp, NIBP, No IBP, resistive color touchscreen 11.6" display with 1366 x 768 resolution, AC or lithium ion rechargeable battery operation; International power cord; AM12 Wired Acquisition Module with AHA 12-lead lead set with snap ends and 1 IEC 5 wire ECG patient cable with clip ends; No invasive blood pressure cable; No cardiac output cable; Internal thermal printer (includes starter pack of thermal paper roll, 1.97 in. x
WELCH ALLYN, INC.
901138
In Commercial Distribution

  • 00732094327090 ()
SUR12-TDH-XXAAX

  • Electrocardiography telemetric monitoring system transmitter
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