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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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The Silaris™ Influenza A&B Control Kit is intended for in vitro diagnostic use in quality control testing with the Silaris™ Influenza A&B Test.
MESA BIOTECH, INC.
1024
In Commercial Distribution

  • B54010240 ()
1024

  • Thermal cycler nucleic acid amplification analyser IVD, point-of-care
TissueStat (TIS-003) is a class I suture deployment device that allows healthcare professionals to place a needle through soft tissue and facilitates the placement of sutures and knot tying for tissue approximation and/or ligation.
Durastat LLC
TIS-003
Not in Commercial Distribution

  • B532TIS0030 ()
TIS-003

  • Suturing needle holder, single-use
Blunt Tip Microcannula Slim Fabinject 27G 38 mm, single use sterile pack with pilot needle - box with 10 units
FABINJECT INDUSTRIA E COMERCIO IMPORTACAO E EXPORTACAO LTDA
BTC27G038BX10 BR
In Commercial Distribution

  • 07898915128628 ()
  • 07898493080578 ()


  • Tissue injection cannula
Blunt Tip Microcannula Slim Fabinject 25G 38 mm, single use sterile pack with pilot needle - box with 10 units
FABINJECT INDUSTRIA E COMERCIO IMPORTACAO E EXPORTACAO LTDA
BTC25G038BX10 BR
In Commercial Distribution

  • 07898915128604 ()
  • 07898493080561 ()


  • Tissue injection cannula
Blunt Tip Microcannula Slim Fabinject 18G 70 mm, single use sterile pack with pilot needle - box with 10 units
FABINJECT INDUSTRIA E COMERCIO IMPORTACAO E EXPORTACAO LTDA
BTC18G070BX10 BR
In Commercial Distribution

  • 07898915128598 ()
  • 07898493080585 ()


  • Tissue injection cannula
The Silaris Dock is an electronic module which executes in vitro diagnostic tests on compatible Silaris 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.
1026
In Commercial Distribution

  • B54010260 ()
1026

  • Thermal cycler nucleic acid amplification analyser IVD, point-of-care
BECKER CYSTOTOME MALLEABLE
SKLAR CORPORATION
65-3020
In Commercial Distribution

  • 10649111432873 ()


  • Ophthalmic knife, reusable
ECONO STERILE DERF NH SERR 4.75" STERL CS25
SKLAR CORPORATION
96-2583A
In Commercial Distribution

  • 50649111487833 ()
  • 10649111487835 ()


  • Suturing needle holder, single-use
Universal Funnel Adapter-Luer Lock
URESIL, LLC
UFA-LL
In Commercial Distribution

  • 20817640020817 ()
  • 00817640020813 ()
  • H862UFALL0 ()
UFA-LL

  • Luer/non-ISO80369-standardized linear connector, 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
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