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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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BIRMINGHAM HIP RESURFACING (BHR) - 03596010559258

BHR SLEEVE CUTTER SIZE 52
Smith & Nephew, Inc.
90129259
In Commercial Distribution

  • 03596010559258 ()
90129259

  • Bone-resection orthopaedic reamer, reusable

BIRMINGHAM HIP - 03596010559234

BIRMINGHAM HIP SLEEVE CUTTER SIZE 48
Smith & Nephew, Inc.
90129258
In Commercial Distribution

  • 03596010559234 ()
90129258

  • Bone-resection orthopaedic reamer, reusable

BIRMINGHAM HIP RESURFACING (BHR) - 03596010559227

BHR SLEEVE CUTTER SIZE 44
Smith & Nephew, Inc.
90129257
In Commercial Distribution

  • 03596010559227 ()
90129257

  • Bone-resection orthopaedic reamer, reusable

BIRMINGHAM HIP RESURFACING (BHR) - 03596010559210

BHR SLEEVE CUTTER SIZE 40
Smith & Nephew, Inc.
90129256
In Commercial Distribution

  • 03596010559210 ()
90129256

  • Bone-resection orthopaedic reamer, reusable

STAR™ - 00886385018102

ANTERTIOR CHAMFER REAMER, 7.5mm
Stryker GmbH
925-0016
Not in Commercial Distribution

  • 00886385018102 ()

  • Outer Diameter: 7.5 Millimeter


  • Bone-resection orthopaedic reamer, reusable

13C-Spirulina GEBT - M763K0211

13C-Spirulina Gastric Emptying Breath Test (GEBT)
ADVANCED BREATH DIAGNOSTICS, LLC
K021
In Commercial Distribution

  • M763K0211 ()


  • Carbon isotope breath test kit IVD

PCM - 00887517083562

PCM Inserter
Nuvasive, Inc.
7690901
In Commercial Distribution

  • 00887517083562 ()


  • Surgical implant/trial-implant/sizer holder, reusable

PCM - 00887517083555

PCM Loading Block
Nuvasive, Inc.
7690900
In Commercial Distribution

  • 00887517083555 ()


  • Surgical implant/trial-implant/sizer holder, reusable

Simplify - 00843285100894

Simplify Slide Hammer
Nuvasive, Inc.
76242
In Commercial Distribution

  • 00843285100894 ()


  • Orthopaedic implantation hammering attachment

Thoratec® HeartMate 3™ - 00813024013143

Tunneling Lance and Handle
Thoratec Corporation
10010372GBL
In Commercial Distribution

  • 00813024013143 ()
10010372GBL

  • Vascular graft tunneller
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