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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 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
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
Box of 5, 20ga Dex Tips™ NanoTapered™ Hybrid Forceps
KATALYST SURGICAL LLC
CVF4007-20
In Commercial Distribution

  • 00817489022764 ()


  • Ophthalmic tissue forceps, single-use
Box of 5, 20ga Dex Tips™ NanoTapered™ Duckbill Forceps
KATALYST SURGICAL LLC
CVF4017-20
In Commercial Distribution

  • 00817489023082 ()


  • Ophthalmic tissue forceps, single-use
Avid IF2 INTERFERENTIAL STIMULATION SYSTEM
Vision Quest Industries Incorporated
AV-IF19A
In Commercial Distribution

  • 00817717021811 ()


  • Interferential electrical stimulation system
ECONO STERILE WEBSTER NH X-FN SMO 5" STER 25
SKLAR CORPORATION
96-2742A
In Commercial Distribution

  • 50649111488298 ()
  • 10649111488290 ()


  • Suturing needle holder, single-use
ECONO STERILE WEBSTER NH X-FIN LG 5" STER 25
SKLAR CORPORATION
96-2741A
In Commercial Distribution

  • 50649111488281 ()
  • 10649111488283 ()


  • Suturing needle holder, single-use
ECONO STERILE WEBSTER NH FINE 5.25" STER 25
SKLAR CORPORATION
96-2740A
In Commercial Distribution

  • 50649111488274 ()
  • 10649111488276 ()


  • Suturing needle holder, single-use
ECONO STERILE OLSEN-HEGAR NH SMO 5.5 STER 25
SKLAR CORPORATION
96-2358A
In Commercial Distribution

  • 50649111488168 ()
  • 10649111488160 ()


  • Suturing needle holder, single-use
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