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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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ECONO STERILE WEBSTER NH SMO 5 1/4 STRL C100
SKLAR CORPORATION
96-2659
In Commercial Distribution

  • 50649111077669 ()
  • 10649111077661 ()


  • Suturing needle holder, single-use
ECONO STERILE MAYO-HEGAR NH 5" STERILE CS/25
SKLAR CORPORATION
96-2599
In Commercial Distribution

  • 50649111066342 ()
  • 10649111066344 ()


  • Suturing needle holder, single-use
ECONO STERILE MAYO-HEGAR NH 6" STERILE CS/25
SKLAR CORPORATION
96-2595
In Commercial Distribution

  • 50649111065642 ()
  • 10649111065644 ()


  • Suturing needle holder, single-use
ECONO STERILE MAYO-HEGAR NH 6" STERILE CS/50
SKLAR CORPORATION
96-2594
In Commercial Distribution

  • 50649111065437 ()
  • 10649111065439 ()


  • Suturing needle holder, single-use
ECONO STERILE CRILE-WOOD NH 6" STERILE CS/25
SKLAR CORPORATION
96-2591
In Commercial Distribution

  • 50649111064799 ()
  • 10649111064791 ()


  • Suturing needle holder, single-use
ASPIRATION FLUSH ADAPTER – LARGE BORE SYSTEM
URESIL, LLC
AFA-LB
In Commercial Distribution

  • 10817640020100 ()
  • 00817640020103 ()
  • 20817640020107 ()
  • H862AFALB0 ()
AFA-LB

  • Luer/non-ISO80369-standardized linear connector, single-use
BECKER CYSTOTOME MALLEABLE
SKLAR CORPORATION
65-3020
In Commercial Distribution

  • 10649111432873 ()


  • Ophthalmic knife, reusable
The Accula™ Flu A / B Control Kit is intended for in vitro diagnostic use in quality control testing with the Accula™ Flu A / B Test.
MESA BIOTECH, INC.
FAB1100CW-C
In Commercial Distribution

  • B540FAB1100CWC0 ()
FAB1100CW-1

  • Thermal cycler nucleic acid amplification analyser IVD, point-of-care
The Programming Cassette is an accessory to the Accula Dock and facilitates reprogramming of the Dock’s embedded firmware. When firmware updates are needed, the firmware will be stored onto Programming Cassettes and sent to end users, who will load the Programming Cassette into their Dock and re-program its firmware
MESA BIOTECH, INC.
D2001
In Commercial Distribution

  • B540D20010 ()
D2001

  • Thermal cycler nucleic acid amplification analyser IVD, point-of-care
The Accula Dock is an electronic module which executes in vitro diagnostic tests on compatible Test Cassettes. It consists of an electro-mechanical interface to a single Test Cassette. The Dock contains all electrical systems, controls and logic necessary to orchestrate in-vitro diagnostic tests within the inserted Test Cassette.
MESA BIOTECH, INC.
D2000
In Commercial Distribution

  • B540D20000 ()
D2000

  • Thermal cycler nucleic acid amplification analyser IVD, point-of-care
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