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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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INVOcell Holding Block - 00862190000327

The INVOcell Holding Block is used with the INVOcell Culture Device to aid in temperature maintenance of the INVOcell Culture Device during loading and collection procedures and to aid in positioning and observation of the INVOcell Culture Device during human gamete/embryo loading and collection procedures. The INVOcell Holding Block is stainless steel with a glass-viewing window.
INVO BIOSCIENCE, INC.
P-007
Not in Commercial Distribution

  • 00862190000327 ()


  • Assisted reproduction procedure dish

Sohn's Dilators - 00861838000323

Dilators used for the treatment of anal fissure.
TOOLS FOR SURGERY, LLC
SOD-03
In Commercial Distribution

  • 00861838000323 ()

  • Outer Diameter: 40 Millimeter
  • Outer Diameter: 35 Millimeter
  • Outer Diameter: 30 Millimeter
SOD-03

  • Rectal dilator, reusable

Gemini 810+980 Diode Laser Kit, International - 00861407000389

No Description
AZENA MEDICAL, LLC
8990
Not in Commercial Distribution

  • 00861407000389 ()


  • Dental diode laser system

Gemini 810+980 Diode Laser - 00861407000303

Dual wavelength super-pulsed dental soft tissue diode laser
AZENA MEDICAL, LLC
EL-5-001
In Commercial Distribution

  • 00861407000303 ()


  • Dental diode laser system

LithoWise - 00861062000359

400 micrometer laser fiber
FIBER OPTIC FABRICATIONS, INC.
LW-1002
In Commercial Distribution

  • 00861062000359 ()


  • General/multiple surgical laser system beam guide, single-use

LithoWise - 00861062000342

940 micrometer laser fiber
FIBER OPTIC FABRICATIONS, INC.
LW-0004
In Commercial Distribution

  • 00861062000342 ()


  • General/multiple surgical laser system beam guide, single-use

LithoWise - 00861062000335

550 micrometer laser fiber
FIBER OPTIC FABRICATIONS, INC.
LW-0003
In Commercial Distribution

  • 00861062000335 ()


  • General/multiple surgical laser system beam guide, single-use

LithoWise - 00861062000328

365 micrometer laser fiber
FIBER OPTIC FABRICATIONS, INC.
LW-0002
In Commercial Distribution

  • 00861062000328 ()

  • Outer Diameter: 365 Micrometer


  • General/multiple surgical laser system beam guide, single-use

LithoWise - 00861062000311

272 micrometer laser fiber
FIBER OPTIC FABRICATIONS, INC.
LW-0001
In Commercial Distribution

  • 00861062000311 ()


  • General/multiple surgical laser system beam guide, single-use

SideWise - 00861062000304

600 micrometer, angled tip, laser fiber
FIBER OPTIC FABRICATIONS, INC.
SW-0001
In Commercial Distribution

  • 00861062000304 ()


  • General/multiple surgical laser system beam guide, single-use
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