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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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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

PULSOX-300 - 00817770020608

Oximeter with Finger Probe
MAXTEC, LLC
R204P16
Not in Commercial Distribution

  • 00817770020608 ()


  • Pulse oximeter

SureMAX - 00817662024592

Cervical Inserter with Guard
ADDITIVE IMPLANTS, LLC
1
In Commercial Distribution

  • 00817662024592 ()

  • Length: 211.3 Millimeter
  • Outer Diameter: 10 Millimeter


  • Orthopaedic inorganic implant inserter/extractor, reusable

Pinnacle - 00817650026195

Chassis With OBS Sensors
Harmar Summit, LLC
Pinnacle, Rave, Leaf
In Commercial Distribution

  • 00817650026195 ()
SSL1200

  • Stairlift, chair

Skylife Controller - 10852788008016

Device Controller (with system)
NEOLIGHT LLC
NL-SK-1
In Commercial Distribution

  • 10852788008016 ()


  • Blanket/pad infant phototherapy unit

Rhausler - 08500591410353

3X18mm Drill with Stop
Rhausler Inc.
C-7044
In Commercial Distribution

  • 08500591410353 ()

  • Length: 18 Millimeter
C-7044

  • Spinal fixation plate, non-bioabsorbable

VYGON - 08498840009796

PROBE COVER WITH BANDS
Vygon Corporation
AMS-9810
In Commercial Distribution

  • 38498840009797 ()
  • 08498840009796 ()
AMS-9810

  • General surgical procedure kit, non-medicated, single-use

BR Surgical, LLC - 00840183516383

Cotton Jar with lid
BR Surgical, LLC
BR83-14300
In Commercial Distribution

  • 00840183516383 ()
BR83-14300

  • Dressing jar

NA - 03663136023410

Distractor with long arms
SPINEVISION
C1 - A227
In Commercial Distribution

  • 03663136023410 ()

  • 0


  • Orthopaedic surgical procedure kit, non-medicated, reusable
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