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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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ExuCare Large with foot - 00850051939381

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 with InspiraMask (Large) - 00852367007013

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 with Tray - 00852306007302

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 - 08057639710574

Tip with Indexable Stop for MCBio Tacks
MC BIO SRL
9570566
In Commercial Distribution

  • 08057639710574 ()


  • Bone tack inserter, basic

Otoport - Screener with ABR - 05060396171062

No Description
OTODYNAMICS LIMITED
OS-ST+ABR
In Commercial Distribution

  • 05060396171062 ()


  • Evoked-potential audiometer

Inspirachamber with Inspiramask (Large) - 00327437043012

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 - 04057034120774

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 - 04057034095393

Flexarm, OPCAB with carrier CardioFrame™
Geister Medizintechnik GmbH
29-1486
In Commercial Distribution

  • 04057034095393 ()
29-1486

  • Self-retaining surgical retractor, reusable

System Drape with Pocket - 00841912100675

No Description
PROTEK MEDICAL PRODUCTS, INC.
1217
In Commercial Distribution

  • 10841912100672 ()
  • 00841912100675 ()
1217

  • Medical equipment/instrument drape, single-use

Mattress with flat surface - 04056869008790

No Description
Siemens Healthcare GmbH
08096856
In Commercial Distribution

  • 04056869008790 ()


  • Full-body CT system
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