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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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A wound cover that wraps around the leg and foot which is intended to be used as an initial, short-term treatment after injury that consists of an absorbent pad (e.g., gauze, cotton wool, lint, cellulose) The device is intended for use in the home or a clinical setting to protect wounds, arrest bleeding. This is a single-use device.
SUN SCIENTIFIC, INC.
EC6350
In Commercial Distribution

  • 00850051939381 ()
ECWF300

  • First aid absorbent pad/bandage
InspiraChamber Anti-Static Valved Holding Chamber with InspiraMask- Hospital Unit
INSPIRX, INC
IC-IML-0
In Commercial Distribution

  • 00852367007013 ()
  • 10852367007010 ()


  • Medicine chamber spacer, reusable
FlexGuide ULTRA set with Fleguide Handpiece and Tray
OMNIGUIDE, INC.
FLEX-ULTRA SET
In Commercial Distribution

  • 00852306007302 ()
FLEX-ULTRA SET

  • Urogenital surgical laser system beam guide, reusable
Tip with Indexable Stop for MCBio Tacks
MC BIO SRL
9570566
In Commercial Distribution

  • 08057639710574 ()


  • Bone tack inserter, basic
No Description
OTODYNAMICS LIMITED
OS-ST+ABR
In Commercial Distribution

  • 05060396171062 ()


  • Evoked-potential audiometer
Inspirachamber Anti-static Valved Holding Chamber with InspiraMask (Large) (Retail Unit)
LUPIN PHARMACEUTICALS, INC.
IPX1043
In Commercial Distribution

  • 30327437043013 ()
  • 00327437043012 ()


  • Medicine chamber spacer, reusable
Hook, with Ball 35cm ValveGate™
Geister Medizintechnik GmbH
34-7486
In Commercial Distribution

  • 04057034120774 ()
34-7486

  • Hand-held surgical retractor, reusable
Flexarm, OPCAB with carrier CardioFrame™
Geister Medizintechnik GmbH
29-1486
In Commercial Distribution

  • 04057034095393 ()
29-1486

  • Self-retaining surgical retractor, reusable
No Description
PROTEK MEDICAL PRODUCTS, INC.
1217
In Commercial Distribution

  • 10841912100672 ()
  • 00841912100675 ()
1217

  • Medical equipment/instrument drape, single-use
No Description
Siemens Healthcare GmbH
08096856
In Commercial Distribution

  • 04056869008790 ()


  • Full-body CT system
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