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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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500 ml Canister (with Gel) for Infovac and VAC Ulta Therapy Systems
KCI USA, INC.
M8275063/5 M8275063/10
In Commercial Distribution

  • 00878237000892 ()
  • 00878237000878 ()


  • Negative-pressure wound therapy system canister
Vac Granufoam Dressing Round Featuring Sensatrac Technology
KCI USA, INC.
M8275075/5 M8275075/10
Not in Commercial Distribution

  • 00878237000748 ()
  • 00878237000762 ()


  • Negative-pressure wound therapy system foam dressing, non-antimicrobial
Bioresorbable protective sheet made from polylactide: a copolymer of 70:30 Poly(L-lactide-co-D,L-lactide). Indicated for use as a pericardium replacement device in patients that may require re-operation within six months.
MAST BIOSURGERY USA INC.
100 x 130 x 0.02mm
Not in Commercial Distribution

  • 18964050362022 ()
  • 08964050362025 ()

  • Length: 130 Millimeter
  • Width: 100 Millimeter
  • Thickness: 0.02 Millimeter
36202-01

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable
SURGUARD2 Safety Hypodermic Needle
TERUMO (PHILIPPINES) CORPORATION
10180094
In Commercial Distribution

  • 54806017512946 ()
  • 34806017512942 ()
  • 14806017512948 ()

  • Needle Gauge: 27 Gauge
  • Length: 0.5 Inch


  • Hypodermic needle, single-use
Infusion Set (1.5 ml/hr)
Rex Pj Tech LLC
BL1D01/5
In Commercial Distribution

  • 10857362007041 ()
  • 00857362007044 ()


  • Prefilled mechanical infusion pump/catheter
VAC Whitefoam Dressing Large Featuring Sensatrac Technology
KCI USA, INC.
M8275067/5
In Commercial Distribution

  • 00849554000810 ()


  • Negative-pressure wound therapy system foam dressing, non-antimicrobial
VAC Whitefoam Dressing Small Featuring Sensatrac Technology
KCI USA, INC.
M8275068/5
In Commercial Distribution

  • 00849554000797 ()


  • Negative-pressure wound therapy system foam dressing, non-antimicrobial
No Description
PHARMACEUTICAL HEALTH LIMITED
5 Count
In Commercial Distribution

  • 5060497630055 ()
  • 05060497630048 ()


  • Synovial fluid supplementation medium
Implantable Pulse Generator
ST. JUDE MEDICAL, INC.
5 Elite
In Commercial Distribution

  • 05415067020192 ()
3660

  • Spinal cord/peripheral nerve implantable analgesic electrical stimulation system pulse generator, implantable
One time use sterile emergency airway kit that contains (1) Disposable Scalpel #10 blade, (1) Endotracheal Tube, 6.0 mm cuffed, (1) 10 cc syringe, (1) 35 cm Bougie and Twill Tape.
H&H MEDICAL CORPORATION
Version 5
In Commercial Distribution

  • 00857048006477 ()

  • Length: 9.25 Inch
  • Width: 4.0 Inch
  • Height: 1.75 Inch
HHRCK01

  • Cricothyrotomy kit, single-use
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