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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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Annex® Introducer, Hook Rotator, Ball Hex
Spine Wave, Inc.
10-5017
In Commercial Distribution

  • 10840642107852 ()
10-5017

  • Surgical implant/trial-implant/sizer holder, reusable
Annex® Inner Sleeve, Annex Introducer
Spine Wave, Inc.
10-5015
In Commercial Distribution

  • 10840642107845 ()
10-5015

  • Surgical implant/trial-implant/sizer holder, reusable
Annex® Outer Sleeve Assembly, Introducer
Spine Wave, Inc.
10-5014
In Commercial Distribution

  • 10840642107838 ()
10-5014

  • Surgical implant/trial-implant/sizer holder, reusable
Dormia 2Fr 8mm Stone Extractor
EPflex Feinwerktechnik GmbH.
DOF208
In Commercial Distribution

  • B937DOF2081 ()
  • B937DOF2080 ()
DOF208

  • Urinary stone retrieval basket, single-use
Dormia 2Fr 11mm Stone Extractor
EPflex Feinwerktechnik GmbH.
DOF201
In Commercial Distribution

  • B937DOF2011 ()
  • B937DOF2010 ()
DOF201

  • Urinary stone retrieval basket, single-use
Dormia 1.5Fr.8mm Stone Extractor
EPflex Feinwerktechnik GmbH.
DOF158
In Commercial Distribution

  • B937DOF1581 ()
  • B937DOF1580 ()
DOF158

  • Urinary stone retrieval basket, single-use
Dormia 1.5Fr 11mm Stone Extractor
EPflex Feinwerktechnik GmbH.
DOF151
In Commercial Distribution

  • B937DOF1511 ()
  • B937DOF1510 ()
DOF151

  • Urinary stone retrieval basket, single-use
Blunt Dissector
Life Spine, Inc.
116-569
In Commercial Distribution

  • 00190837032883 ()
116-569

  • Bone curette, reusable
5.5mm Rod/Cross Connector Holder
Life Spine, Inc.
148-107
In Commercial Distribution

  • 00190837032807 ()
148-107

  • Surgical implant/trial-implant/sizer holder, reusable
VAGINAL SPECULUM, DISPOSABLE, SMALL, WHITE, NON-STERILE, 1 EACH
Asp Global, LLC
IVT501
In Commercial Distribution

  • 00840216101432 ()


  • Vaginal speculum, single-use
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