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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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CardioWrap® - 08964050362025

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

Natural Extensions - 00366975000620

Mask, Earloop, Lavender
BENCO DENTAL SUPPLY CO.
3414-744
In Commercial Distribution

  • 20366975000624 ()
  • 10366975000627 ()
  • 00366975000620 ()


  • Surgical/medical face mask, single-use

KWIK-STIK™ Plus - 10845357012057

KWIK-STIK™ Plus A. niger ATCC 6275™
MICROBIOLOGICS INC.
0500UX
Not in Commercial Distribution

  • 40845357012058 ()
  • 10845357012057 ()
0500UX

  • Multiple bacteria species culture isolate identification control IVD, kit

KWIK-STIK™ Plus - 10845357011760

KWIK-STIK™ Plus B. cepacia ATCC 25416™
MICROBIOLOGICS INC.
0488UX
Not in Commercial Distribution

  • 40845357011761 ()
  • 10845357011760 ()
0488UX

  • Multiple bacteria species culture isolate identification control IVD, kit

KWIK-STIK™ Plus - 10845357011715

KWIK-STIK™ Plus C. sporogenes ATCC 11437™
MICROBIOLOGICS INC.
0487UX
Not in Commercial Distribution

  • 40845357011716 ()
  • 10845357011715 ()
0487UX

  • Multiple bacteria species culture isolate identification control IVD, kit

KWIK-STIK™ Plus - 10845357011647

KWIK-STIK™ Plus B. spizizenii ATCC 6633™
MICROBIOLOGICS INC.
0486UX
Not in Commercial Distribution

  • 40845357011648 ()
  • 10845357011647 ()
0486UX

  • Multiple bacteria species culture isolate identification control IVD, kit

KWIK-STIK™ Plus - 10845357011548

KWIK-STIK™ Plus S. aureus ATCC 6538™
MICROBIOLOGICS INC.
0485UX
Not in Commercial Distribution

  • 40845357011549 ()
  • 10845357011548 ()
0485UX

  • Multiple bacteria species culture isolate identification control IVD, kit

KWIK-STIK™ Plus - 10845357011449

KWIK-STIK™ Plus P. aeruginosa ATCC 9027™
MICROBIOLOGICS INC.
0484UX
Not in Commercial Distribution

  • 40845357011440 ()
  • 10845357011449 ()
0484UX

  • Multiple bacteria species culture isolate identification control IVD, kit

KWIK-STIK™ Plus - 10845357011371

KWIK-STIK™ Plus E. coli ATCC 8739™
MICROBIOLOGICS INC.
0483UX
Not in Commercial Distribution

  • 40845357011372 ()
  • 10845357011371 ()
0483UX

  • Multiple bacteria species culture isolate identification control IVD, kit

KWIK-STIK™ Plus - 10845357010411

KWIK-STIK™ Plus B. vulgatus ATCC 8482™
MICROBIOLOGICS INC.
0445UX
Not in Commercial Distribution

  • 40845357010412 ()
  • 10845357010411 ()
0445UX

  • Multiple bacteria species culture isolate identification control IVD, kit

KWIK-STIK™ Plus - 10845357010336

KWIK-STIK™ Plus C. albicans ATCC 10231™
MICROBIOLOGICS INC.
0443UX
Not in Commercial Distribution

  • 40845357010337 ()
  • 10845357010336 ()
0443UX

  • Multiple bacteria species culture isolate identification control IVD, kit

KWIK-STIK™ Plus - 10845357009675

KWIK-STIK™ Plus S. Typhimurium ATCC 13311™
MICROBIOLOGICS INC.
0421UX
Not in Commercial Distribution

  • 40845357009676 ()
  • 10845357009675 ()
0421UX

  • Multiple bacteria species culture isolate identification control IVD, kit

KWIK-STIK™ Plus - 10845357009606

KWIK-STIK™ Plus C. acnes ATCC 11827™
MICROBIOLOGICS INC.
0419UX
Not in Commercial Distribution

  • 40845357009607 ()
  • 10845357009606 ()
0419UX

  • Multiple bacteria species culture isolate identification control IVD, kit

KWIK-STIK™ Plus - 10845357008821

KWIK-STIK™ Plus A. brasiliensis ATCC 16404™
MICROBIOLOGICS INC.
0392UX
Not in Commercial Distribution

  • 40845357008822 ()
  • 10845357008821 ()
0392UX

  • Multiple bacteria species culture isolate identification control IVD, kit

KWIK-STIK™ Plus - 10845357008531

KWIK-STIK™ Plus S. pyogenes (A) ATCC 19615™
MICROBIOLOGICS INC.
0385UX
Not in Commercial Distribution

  • 40845357008532 ()
  • 10845357008531 ()
0385UX

  • Multiple bacteria species culture isolate identification control IVD, kit

KWIK-STIK™ Plus - 10845357008135

KWIK-STIK™ Plus S. epidermidis ATCC 12228™
MICROBIOLOGICS INC.
0371UX
Not in Commercial Distribution

  • 40845357008136 ()
  • 10845357008135 ()
0371UX

  • Multiple bacteria species culture isolate identification control IVD, kit

KWIK-STIK™ Plus - 10845357008012

KWIK-STIK™ Plus S. maltophilia ATCC 13637™
MICROBIOLOGICS INC.
0369UX
Not in Commercial Distribution

  • 40845357008013 ()
  • 10845357008012 ()
0369UX

  • Multiple bacteria species culture isolate identification control IVD, kit

KWIK-STIK™ Plus - 10845357007909

KWIK-STIK™ Plus E. faecalis ATCC 29212™
MICROBIOLOGICS INC.
0366UX
Not in Commercial Distribution

  • 40845357007900 ()
  • 10845357007909 ()
0366UX

  • Multiple bacteria species culture isolate identification control IVD, kit

KWIK-STIK™ Plus - 10845357007763

KWIK-STIK™ Plus S. Typhimurium ATCC 14028™
MICROBIOLOGICS INC.
0363UX
Not in Commercial Distribution

  • 40845357007764 ()
  • 10845357007763 ()
0363UX

  • Multiple bacteria species culture isolate identification control IVD, kit

KWIK-STIK™ Plus - 10845357007657

KWIK-STIK™ Plus S. aureus ATCC 25923™
MICROBIOLOGICS INC.
0360UX
Not in Commercial Distribution

  • 40845357007658 ()
  • 10845357007657 ()
0360UX

  • Multiple bacteria species culture isolate identification control IVD, kit
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