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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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Oakworks Medical - 00817463020021

CFPM401 with 2" Pad
OAKWORKS, INC.
CFPM401
In Commercial Distribution

  • 00817463020021 ()


  • Radiological general body-part positioner

Oakworks Medical - 00817463020014

CFPM401 with Integrated Top
OAKWORKS, INC.
CFPM401
In Commercial Distribution

  • 00817463020014 ()


  • Radiological general body-part positioner

N/A - 00817470009231

SUTURE CLAMP WITH TENSIOMETER
Smith & Nephew, Inc.
21-1004
Not in Commercial Distribution

  • 00817470009231 ()
21-1004

  • Tendon/ligament graft preparation station post

SMARTSTITCH M-CONNECTOR - 00817470007398

SMARTSTITCH WITH MW WHITE
Smith & Nephew, Inc.
OM-8075
In Commercial Distribution

  • 20817470007392 ()
  • 00817470007398 ()
OM-8075

  • Arthroscopic suturing unit

SMARTSTITCH M-CONNECTOR - 00817470007381

SMARTSTITCH WITH MW WHITE
Smith & Nephew, Inc.
OM-8075EA
In Commercial Distribution

  • 00817470007381 ()
OM-8075EA

  • Arthroscopic suturing unit

BIONIX RADIATION THERAPY - 00817740020713

TRIVAC WITH BOLSTER CUSHION
Bionix Radiation Therapy, LLC
SVRT-7650
Not in Commercial Distribution

  • 00817740020713 ()
SVRT-7650

  • Radiological whole-body positioner

TRYPTIK ® TI - 07640450863423

IMPLANT HOLDER WITH STOP
SpineArt SA
TRY-IN 50 02-N
In Commercial Distribution

  • 07640450863423 ()
TRY-IN 50 02-N

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

SAMPEDRO - 07708626670951

Jacobs chuck with T-handle
INDUSTRIAS MEDICAS SAMPEDRO S A S
0
In Commercial Distribution

  • 07708626670951 ()
/TTTP

  • Orthopaedic broach

MAXO2+ - 00817770020943

Analyzer with Optiflow Jr.
MAXTEC, LLC
R219P17-003
Not in Commercial Distribution

  • 00817770020943 ()


  • Respiratory oxygen monitor, line-powered

PULSOX-300i - 00817770020639

Oximeter with Finger Probe
MAXTEC, LLC
R204P17
Not in Commercial Distribution

  • 00817770020639 ()


  • Pulse oximeter
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