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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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Anterior Cervical IBFD - B084AC1111306000

No Description
KEOS
11D x 13W x 06H x 0L, PEEK
In Commercial Distribution

  • B084AC1111306000 ()
AC1-111306-00

  • Polymeric spinal interbody fusion cage

Anterior Cervical IBFD - B084AC1111305070

No Description
KEOS
11D x 13W x 05H x 7L, PEEK
In Commercial Distribution

  • B084AC1111305070 ()
AC1-111305-07

  • Polymeric spinal interbody fusion cage

Anterior Cervical IBFD - B084AC1111305040

No Description
KEOS
11D x 13W x 05H x 4L, PEEK
In Commercial Distribution

  • B084AC1111305040 ()
AC1-111305-04

  • Polymeric spinal interbody fusion cage

Anterior Cervical IBFD - B084AC1111305000

No Description
KEOS
11D x 13W x 05H x 0L, PEEK
In Commercial Distribution

  • B084AC1111305000 ()
AC1-111305-00

  • Polymeric spinal interbody fusion cage

ValuTrode X Tan Cloth - 00856817005314

No Description
AXELGAARD MANUFACTURING CO., LTD.
VTXT505
In Commercial Distribution

  • 00856817005314 ()


  • Transcutaneous electrical stimulation electrode, single-use
  • Transcutaneous electrical stimulation electrode, reusable

ValuTrode X Tan Cloth - 00856817005307

No Description
AXELGAARD MANUFACTURING CO., LTD.
VTXT500
In Commercial Distribution

  • 00856817005307 ()


  • Transcutaneous electrical stimulation electrode, single-use
  • Transcutaneous electrical stimulation electrode, reusable

n•x•t Microcuvette - 00657498000236

For the quantitative determination of hemoglobin in capillary, venous or arterial whole blood.
STANBIO LABORATORY, L.P.
3025-050
In Commercial Distribution

  • 00657498000236 ()
  • 00657498001455 ()
3025-050

  • Haemoglobin analyser IVD, point-of-care

2.25" x 2.50" electrode - 00857771003804

100 (5 pouches/bag)
BIOMEDICAL LIFE SYSTEMS, INC.
EDRC225250
Not in Commercial Distribution

  • 00857771003804 ()
EDRC225250

  • Transcutaneous electrical stimulation electrode, single-use

2.25" x 2.50" electrode - 00857771003309

20 per pouch
BIOMEDICAL LIFE SYSTEMS, INC.
EDRC225250
Not in Commercial Distribution

  • 00857771003309 ()
  • 10857771003306 ()
  • 20857771003303 ()
EDRC225250

  • Transcutaneous electrical stimulation electrode, single-use

iFUSE INTRA X Assist - 00857676008560

No Description
Eca Medical Instruments
973-002
In Commercial Distribution

  • 00857676008560 ()
501986

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

iFUSE INTRA X Mallet - 00857676008553

No Description
Eca Medical Instruments
973-001
In Commercial Distribution

  • 00857676008553 ()
501984

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

RANGE CHECK X lll - 14987562460387

Range Check X lll 24X3.0ML WBC/RBC/PLT
SYSMEX CORPORATION
218981
Not in Commercial Distribution

  • 14987562460387 ()

  • Total Volume: 3 Milliliter


  • Full blood count IVD, control

RANGE CHECK X ll - 14987562460257

Range Check X ll
SYSMEX CORPORATION
130-4003-0
Not in Commercial Distribution

  • 14987562460257 ()

  • Total Volume: 2 Milliliter


  • Full blood count IVD, control

CALIBRATED 3.2MM X 250MM - 00880304511262

No Description
Biomet Orthopedics, LLC
27565
In Commercial Distribution

  • 00880304511262 ()

  • 3.2MM X 250MM
27565

  • Fluted surgical drill bit, single-use

X FIX Dynafix System - 00880304509986

No Description
Biomet Orthopedics, LLC
13150
In Commercial Distribution

  • 00880304509986 ()

  • 1.6 MM Ø 350 MM LENGTH
13150

  • Medullary canal orthopaedic reamer, rigid

X FIX DYNAFIX SYSTEM - 00880304505162

No Description
Biomet Orthopedics, LLC
13125
In Commercial Distribution

  • 00880304505162 ()

  • 1.6 MM Ø 400 MM LENGTH
13125

  • External orthopaedic fixation system, single-use

X FIX DYNAFIX SYSTEM - 00880304529267

No Description
Biomet Orthopedics, LLC
13120
In Commercial Distribution

  • 00880304529267 ()

  • 1.6 MM Ø 350 MM LENGTH
13120

  • External orthopaedic fixation system, single-use

CALIBRATED 4.3MM X 250MM - 00880304509573

No Description
Biomet Orthopedics, LLC
27557
In Commercial Distribution

  • 00880304509573 ()

  • 4.3MM X 250MM
27557

  • Fluted surgical drill bit, single-use

CALIBRATED 2.7MM X 250MM - 00880304508514

No Description
Biomet Orthopedics, LLC
27570
In Commercial Distribution

  • 00880304508514 ()

  • 2.7MM X 250MM
27570

  • Fluted surgical drill bit, single-use

CALIBRATED 4.8MM X 250MM - 00880304507654

No Description
Biomet Orthopedics, LLC
27550
In Commercial Distribution

  • 00880304507654 ()

  • 4.8MM X 250MM
27550

  • Fluted surgical drill bit, single-use
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