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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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KC LARGE MAYO STD.COV.
O&M HALYARD, INC.
77452
In Commercial Distribution

  • 30680651774522 ()
  • 10680651774528 ()


  • Instrument/equipment drape, single-use, sterile
ASCB Installation Tools and Hardware Kit
ATRICURE, INC.
ASCB
In Commercial Distribution

  • 00818354016444 ()
A000810

  • Instrument trolley
Fusion Cart
ATRICURE, INC.
ASCF
In Commercial Distribution

  • 00818354014754 ()
A000951

  • Instrument trolley
HALYARD BASICS* Mayo Stand Cover-32 x 57-Standard Telescopic Fold-Standard Packaging-65-1-65-X-Large
O&M HALYARD, INC.
88672
In Commercial Distribution

  • 10680651886726 ()
  • 30680651886720 ()


  • Instrument/equipment drape, single-use, sterile
HALYARD BASICS* Mayo Stand Cover-23 x 54-Standard Telescopic Fold-Standard Packaging-80-1-80-Regular
O&M HALYARD, INC.
88665
In Commercial Distribution

  • 10680651886658 ()
  • 30680651886652 ()


  • Instrument/equipment drape, single-use, sterile
AlbiQuick™, for Candida albicans differentiation, 5 minute test, 25 tests per kit The new Hardy AlbiQuick™ utilizes two enzyme color reactions to produce an accurate result that’s easy to read out. AlbiQuick is performed on a convenient card with two reaction wells. Only Candida albicans possesses the enzymes that will hydrolyze the PRO and NAG compounds on the card. Incubation time is only five minutes at room temperature! Requires the use of a handheld 366nm ultra violet lamp(see Cat. no. UVL56). The old germ tube method of C. albicans identification requires several hours of incubation and tedious microscopy to produce a result. The AlbiQuick™ eliminates the need for this and other lengthy procedures. A recent study, which compared the above NAG and PRO methods to the traditional germ tube test, showed a sensitivity of 99% and a specificity of 99-100% (the germ tube test showed a sensitivity of 95% and a specificity of 99%; all isolates confirmed by API 20C). Ref: Crist, et al, J. Clin. Microbiol. 34:2616-2618. Accurate, fast, and convenient...that’s AlbiQuick™! Contains: Albiquick Test Cards (25) 00819398027298 Albiquick Reagent A (1) 00816576029051 Developer Reagent (1) 00819398028585
HARDY DIAGNOSTICS
Z121
In Commercial Distribution

  • 00819398028608 ()
Z121

  • Candida albicans/C. glabrata antigen IVD, kit, agglutination, rapid
Grip for rectoscope
SAPI MED SPA
A.4131
In Commercial Distribution

  • 08033638800232 ()
  • 08033638800225 ()
A.4131

  • Surgical instrument containment holder, single-use, non-sterile
This device is an under counter washer disinfector designed for the cleaning, thermal disinfection (intermediate level) and forced hot air drying of instruments used in surgeries, dental instruments and laboratory glassware.
STEELCO SPA
DS 610/2
In Commercial Distribution

  • 08033609173150 ()
DS 610/2

  • Surgical utensil washer/disinfector
The device is a large capacity washer disinfector dedicated to the treatment of transport, storage and waste trolleys. It offers complete cleaning and thermal disinfection (intermediate level) treatment.
STEELCO SPA
LC 80/3
In Commercial Distribution

  • 08033609173082 ()
LC 80/3

  • Surgical utensil washer/disinfector
Waterproof Foam Tape, 1 roll, 1 IN x 5 YDS (25 mm x 4.5 m)
HARMON STORES, INC.
017276236637
In Commercial Distribution

  • 10017276236634 ()
  • 00017276236637 ()


  • Waterproof skin adhesive tape
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