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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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Arthrex® - 00888867190962

Punch with cortical tap
ARTHREX, INC.
AR-1927CTB-2
In Commercial Distribution

  • 00888867190962 ()
AR-1927CTB-2

  • Bone tap, reusable

Arthrex® - 00888867120976

FIBERTAPE, BLUE WITH NEEDLES
ARTHREX, INC.
AR-7237-7N
Not in Commercial Distribution

  • 00888867120976 ()
AR-7237-7N

  • Polyolefin/fluoropolymer suture, multifilament

Arthrex® - 00888867118140

DUALWAVE WITH REMOTE SET
ARTHREX, INC.
AR-6480-SR
Not in Commercial Distribution

  • 00888867118140 ()
  • M150AR6480SR0 ()
AR-6480-SR

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

Surgical Direct - B382SD12499A0

Cholangiogram Forceps with Ratchet
Surgical Direct, Inc.
SD12499A
In Commercial Distribution

  • B382SD12499A0 ()
SD12499A

  • Flexible endoscopic tissue manipulation forceps, single-use

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
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