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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 Class Implantable

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Esteem® Intraoperative System Analyzer - 00812282020160

Intraoperative System Analyzer (ISA), Software and Computer
Envoy Medical Corporation
3001
In Commercial Distribution

  • 00812282020160 ()
903001-003

  • Fully-implantable middle ear implant system

STRAUMANN COMPUTER AIDED RESTORATION SERVICE - 07630031717764

Custom Abutment Ti, RN, incl. TAN screw
Institut Straumann AG
Final Abutments
In Commercial Distribution

  • 07630031717764 ()
040.689

  • Dental implant suprastructure, permanent, preformed

Straumann Computer Aided Restoration Service (C.A.R.E.S.) Ceramic Coping - 07630031717757

Custom Abutment Zirconia, for Straumann RN, incl. TAN screw
Institut Straumann AG
Final Abutments
In Commercial Distribution

  • 07630031717757 ()
040.688

  • Dental implant suprastructure, permanent, preformed

Straumann Computer Aided Restoration Service (C.A.R.E.S.) Ceramic Coping - 07630031728913

RN Screw for CARES® Abutment, ZrO2 , and instructions for use
Institut Straumann AG
Screws
In Commercial Distribution

  • 07630031728913 ()
048.788

  • Dental prosthesis/implant abutment screw

Sureform - 00886874121931

8mm Stapler
INTUITIVE SURGICAL, INC.
48230M
In Commercial Distribution

  • 10886874121938 ()
  • 00886874121931 ()

  • Depth: 30 Millimeter


  • Surgical staple loading unit, non-cutting

Sureform - 00886874121924

8mm Stapler
INTUITIVE SURGICAL, INC.
48230W
In Commercial Distribution

  • 10886874121921 ()
  • 00886874121924 ()

  • Depth: 30 Millimeter


  • Surgical staple loading unit, non-cutting

Sureform - 00886874121917

8mm Stapler
INTUITIVE SURGICAL, INC.
48230B
In Commercial Distribution

  • 10886874121914 ()
  • 00886874121917 ()

  • Depth: 30 Millimeter


  • Surgical staple loading unit, non-cutting

SureForm - 00886874117125

SUREFORM 45 RELOAD WHITE
INTUITIVE SURGICAL, INC.
48345W
In Commercial Distribution

  • 10886874117122 ()
  • 00886874117125 ()

  • Depth: 2.5 Millimeter


  • Surgical staple loading unit, non-cutting

SureForm - 00886874117118

SUREFORM 45 RELOAD BLACK
INTUITIVE SURGICAL, INC.
48345T
In Commercial Distribution

  • 10886874117115 ()
  • 00886874117118 ()

  • Depth: 4.6 Millimeter


  • Surgical staple loading unit, non-cutting

SureForm - 00886874117101

SUREFORM 45 RELOAD GRAY
INTUITIVE SURGICAL, INC.
48345M
In Commercial Distribution

  • 10886874117108 ()
  • 00886874117101 ()

  • Depth: 2 Millimeter


  • Surgical staple loading unit, non-cutting
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