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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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OPERACE - 07610733850570

Sterile single use insert for the removal of intact screws
PB SWISS TOOLS AG
80057
In Commercial Distribution

  • 07610733850570 ()
80057

  • Surgical screwdriver, single-use

OPERACE - 07610733850563

Sterile single use insert for the removal of intact screws
PB SWISS TOOLS AG
80056
In Commercial Distribution

  • 07610733850563 ()
80056

  • Surgical screwdriver, single-use

OPERACE - 07610733850556

Sterile single use insert for the removal of intact screws
PB SWISS TOOLS AG
80055
In Commercial Distribution

  • 07610733850556 ()
80055

  • Surgical screwdriver, single-use

OPERACE - 07610733850266

Drill Bit for the removal of stuck locking-head screws, the screw head is separated from the screw schaft by drilling
PB SWISS TOOLS AG
80026
In Commercial Distribution

  • 07610733850266 ()
80026

  • Fluted surgical drill bit, single-use

Barbell Loop Ostomy Device - 00860002701325

Loop Ostomy Device, Small (2-inch rod).
TOOLS FOR SURGERY, LLC
BAR-2
In Commercial Distribution

  • 00860002701325 ()

  • Length: 2 Inch
BAR-2

  • Colostomy rod

SIREN SGT - 00860002701363

Suction-regulated orogastric calibration tube, 36 Fr
TOOLS FOR SURGERY, LLC
SGT-36
In Commercial Distribution

  • 00860002701363 ()

  • Outer Diameter: 12 Millimeter
SGT-36

  • Nasogastric/orogastric tube

Bariatric Air Syringe - 00861838000378

Expedite and standardize the 'bubble test' for gastrojejunal anastomoses and sleeve gastrectomy.
TOOLS FOR SURGERY, LLC
ALT-BA
In Commercial Distribution

  • 00861838000378 ()

  • Length: 6.76 Inch
ALT-BA

  • Endoscope inflation bulb

Kick 2 Navigation Station EM - 04056481143725

The platform hosts one or more Brainlab Software Applications. It incorporates a computer and display unit to facilitate the display, exchange, processing and interaction with data and tracking for Imaged Guided Surgery (IGS) purposes.
Brainlab AG
18202
In Commercial Distribution

  • 04056481143725 ()


  • Electromagnetic/optical surgical navigation device tracking system

FUKUDA DENSHI - 04538612916014

No Description
FUKUDA DENSHI CO.,LTD.
FP-908LP
In Commercial Distribution

  • 04538612916014 ()


  • Software upgrade/unlocking key

FUKUDA DENSHI - 04538612916007

No Description
FUKUDA DENSHI CO.,LTD.
FP-908A
In Commercial Distribution

  • 04538612916007 ()


  • Software upgrade/unlocking key
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