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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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OsteoMed - 00845694094443

213-1601, Grey ID Tag, T
OSTEOMED LLC
220-0644-109
In Commercial Distribution

  • 00845694094443 ()
220-0644-109

  • General internal orthopaedic fixation system implantation kit

HA FOOTPLATE SHOE - 00844505000215

HA FOOTPLATE SHOE 1MM ID
Grace Medical, Inc.
192
In Commercial Distribution

  • 00844505000215 ()


  • Ossicular prosthesis, partial

Parasol Wireless Patient Fall Prevention System - 00854636006642

Wireless Falls Monitor ID Key
Parasol Medical, LLC
KEY01
In Commercial Distribution

  • 00854636006642 ()

  • Mono Plug Diameter: 0.125 Inch


  • Inpatient motion surveillance unit

Ventlab - 10889483107805

19mm ID Adjustable PEEP Valve
VENTLAB, LLC
VP700
Not in Commercial Distribution

  • 20889483107802 ()
  • 10889483107805 ()

  • Outer Diameter: 30 Millimeter
  • Lumen/Inner Diameter: 19 Millimeter
VP700

  • PEEP valve, single-use

Ventlab - 10889483107812

30mm ID Adjustable PEEP Valve
VENTLAB, LLC
VP701
In Commercial Distribution

  • 20889483107819 ()
  • 10889483107812 ()

  • Outer Diameter: 30 Millimeter
  • Lumen/Inner Diameter: 19 Millimeter


  • PEEP valve, single-use

DxTx Medical 1.5T eCoil Imaging Device (for GE) - 00850011472224

Ecoil ID - 1.5T GE - M64ERA8-P
DXTX MEDICAL INC
M64ERA8-P
In Commercial Distribution

  • 00850011472224 ()


  • MRI system coil, radio-frequency

DxTx Medical 1.5T eCoil Imaging Device (for Siemens) - 00850011472217

Ecoil ID - FID SYM FRU
DXTX MEDICAL INC
FID SYM FRU
In Commercial Distribution

  • 00850011472217 ()


  • MRI system coil, radio-frequency

DxTx Medical 1.5T eCoil Imaging Device (for GE) - 00850011472071

Ecoil ID - 1.5T GE - M64ERA8-HD
DXTX MEDICAL INC
M64ERA8-HD
In Commercial Distribution

  • 00850011472071 ()


  • MRI system coil, radio-frequency

DxTx Medical 3T eCoil Imaging Device (for GE) - 00850011472064

Ecoil ID - 3.0T GE - M128ERA8-HD
DXTX MEDICAL INC
M128ERA8-HD
In Commercial Distribution

  • 00850011472064 ()


  • MRI system coil, radio-frequency

REMEL - 00848838004223

Strep ID Quad 10/PK
REMEL, INC.
R02475
Not in Commercial Distribution

  • 00848838004223 ()
R02475

  • Differential/selective agar culture medium IVD

REMEL - 00848838004186

Haemophilus ID Quad 10/PK
REMEL, INC.
R02460
In Commercial Distribution

  • 00848838004186 ()
R02460

  • Differential/selective agar culture medium IVD

Adscope® - 00634782098483

Scope ID Tag, Engravable,Black
AMERICAN DIAGNOSTIC CORP
697BKL
In Commercial Distribution

  • 00634782899875 ()
  • 00634782098483 ()
697BKL

  • Mechanical external stethoscope

Medtronic Reusable Instruments - 00613994944825

TAP EX0111148 3.0MM SMALL ID
MEDTRONIC SOFAMOR DANEK, INC.
EX0111148
In Commercial Distribution

  • 00613994944825 ()


  • Bone tap, reusable

OsteoMed - 00845694058452

BLANK Blue ID Tag, 2.0mm
OSTEOMED LLC
220-0640-00
In Commercial Distribution

  • 00845694058452 ()
220-0640-00

  • General internal orthopaedic fixation system implantation kit

OsteoMed - 00845694058407

NON-LOCKING White ID Tag, NON-LOCKING
OSTEOMED LLC
220-0641-38
In Commercial Distribution

  • 00845694058407 ()
220-0641-38

  • General internal orthopaedic fixation system implantation kit

OsteoMed - 00845694058391

LOCKING White ID Tag, LOCKING
OSTEOMED LLC
220-0641-37
In Commercial Distribution

  • 00845694058391 ()
220-0641-37

  • General internal orthopaedic fixation system implantation kit

OsteoMed - 00845694058247

212-0134 White ID Tag, SQUARE
OSTEOMED LLC
220-0641-24
In Commercial Distribution

  • 00845694058247 ()
220-0641-24

  • General internal orthopaedic fixation system implantation kit

OsteoMed - 00845694058209

212-0080 White ID Tag, ORBITAL
OSTEOMED LLC
220-0641-20
In Commercial Distribution

  • 00845694058209 ()
220-0641-20

  • General internal orthopaedic fixation system implantation kit

OsteoMed - 00845694058186

212-0068 White ID Tag, X
OSTEOMED LLC
220-0641-18
In Commercial Distribution

  • 00845694058186 ()
220-0641-18

  • General internal orthopaedic fixation system implantation kit

OsteoMed - 00845694058032

212-0032 White ID Tag, H
OSTEOMED LLC
220-0641-03
In Commercial Distribution

  • 00845694058032 ()
220-0641-03

  • General internal orthopaedic fixation system implantation kit
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