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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CATHETER FG15150-0615-1S V04
Micro Therapeutics, Inc.
FG15150-0615-1S
In Commercial Distribution

  • 00847536041868 ()


  • Vascular guide-catheter, single-use
CATHETER FG15135-0615-1S V04
Micro Therapeutics, Inc.
FG15135-0615-1S
In Commercial Distribution

  • 00847536041851 ()


  • Vascular guide-catheter, single-use
Dental post reamer
HAGER WORLDWIDE, INC.
355996
In Commercial Distribution

  • D2483559960 ()
  • D2483559961 ()


  • Root canal post, preformed
27+® Advanced DSP Backflush Soft Tip
Alcon Laboratories, Inc.
337.88
In Commercial Distribution

  • 17612717071411 ()
  • 07612717071414 ()


  • Vitrectomy fluid/gas handling handpiece/cannula
27+® Advanced DSP Backflush Blunt
Alcon Laboratories, Inc.
337.87
In Commercial Distribution

  • 17612717071404 ()
  • 07612717071407 ()


  • Vitrectomy fluid/gas handling handpiece/cannula
27+® Advanced DSP Tip Straight Scissors
Alcon Laboratories, Inc.
727.53
In Commercial Distribution

  • 17612717071367 ()
  • 07612717071360 ()


  • Intraocular scissors, probe-like, single-use
27+® Advanced DSP Tip ILM Forceps
Alcon Laboratories, Inc.
727.44
In Commercial Distribution

  • 17612717071350 ()
  • 07612717071353 ()


  • Ophthalmic soft-tissue surgical forceps probe-tip, single-use
27+® Advanced DSP Tip EndgraspingForceps
Alcon Laboratories, Inc.
727.43
In Commercial Distribution

  • 17612717071343 ()
  • 07612717071346 ()


  • Ophthalmic soft-tissue surgical forceps probe-tip, single-use
CATHETER FG15160-0615-1S V06 US
Micro Therapeutics, Inc.
FG15160-0615-1S
In Commercial Distribution

  • 00763000399726 ()


  • Vascular microcatheter
CATHETER FG15150-0630-1S V06 US
Micro Therapeutics, Inc.
FG15150-0630-1S
In Commercial Distribution

  • 00763000399719 ()


  • Vascular guide-catheter, single-use
CATHETER FG15150-0615-1S V06 US
Micro Therapeutics, Inc.
FG15150-0615-1S
In Commercial Distribution

  • 00763000399702 ()


  • Vascular guide-catheter, single-use
Power Breast Pump Model Number EP01
WILLOW INNOVATIONS, INC.
01
In Commercial Distribution

  • 05060442520035 ()


  • Breast pump, electric
Orthex SB Number Clip #6 VIOLET
VILEX IN TENNESSEE, INC.
CS-12-6
In Commercial Distribution

  • 00841731123411 ()


  • External orthopaedic fixation system, single-use
Orthex SB Number Clip #4 GREEN
VILEX IN TENNESSEE, INC.
CS-12-4
In Commercial Distribution

  • 00841731123398 ()


  • External orthopaedic fixation system, single-use
Orthex SB Number Clip #3 YELLOW
VILEX IN TENNESSEE, INC.
CS-12-3
In Commercial Distribution

  • 00841731123381 ()


  • External orthopaedic fixation system, single-use
Orthex SB Number Clip #2 ORANGE
VILEX IN TENNESSEE, INC.
CS-12-2
In Commercial Distribution

  • 00841731123374 ()


  • External orthopaedic fixation system, single-use
Orthex SB Number Clip #1 RED
VILEX IN TENNESSEE, INC.
CS-12-1
In Commercial Distribution

  • 00841731123367 ()


  • External orthopaedic fixation system, single-use
Orthex SB Number Clip #6 VIOLET
VILEX IN TENNESSEE, INC.
CS-19-6
In Commercial Distribution

  • 00841731115638 ()


  • External orthopaedic fixation system, single-use
Orthex SB Number Clip #5 BLUE
VILEX IN TENNESSEE, INC.
CS-19-5
In Commercial Distribution

  • 00841731115621 ()


  • External orthopaedic fixation system, single-use
Orthex SB Number Clip #4 GREEN
VILEX IN TENNESSEE, INC.
CS-19-4
In Commercial Distribution

  • 00841731115614 ()


  • External orthopaedic fixation system, single-use
Orthex SB Number Clip #3 GOLD
VILEX IN TENNESSEE, INC.
CS-19-3
In Commercial Distribution

  • 00841731115607 ()


  • External orthopaedic fixation system, single-use
Orthex SB Number Clip #2 ORANGE
VILEX IN TENNESSEE, INC.
CS-19-2
In Commercial Distribution

  • 00841731115591 ()


  • External orthopaedic fixation system, single-use
Orthex SB Number Clip #1 RED
VILEX IN TENNESSEE, INC.
CS-19-1
In Commercial Distribution

  • 00841731115584 ()


  • External orthopaedic fixation system, single-use
SCREW PART NUMBER INSERT FOR 401.558-401.568
Synthes GmbH
306.799
In Commercial Distribution

  • H9803067990 ()
  • 10887587034805 ()
306799

  • Surgical instrument/implant rack
SCREW PART NUMBER INSERT FOR 497.690-497.695
Synthes GmbH
306.798
In Commercial Distribution

  • H9803067980 ()
  • 10887587034799 ()
306798

  • Surgical instrument/implant rack
SCREW PART NUMBER INSERT FOR 497.668-497.678
Synthes GmbH
306.797
In Commercial Distribution

  • H9803067970 ()
  • 10887587034782 ()
306797

  • Surgical instrument/implant rack
SCREW PART NUMBER INSERT FOR 401.508-401.518
Synthes GmbH
306.796
In Commercial Distribution

  • H9803067960 ()
  • 10887587034775 ()
306796

  • Surgical instrument/implant rack
SCREW PART NUMBER INSERT FOR 401.791-401.799
Synthes GmbH
306.795
In Commercial Distribution

  • H9803067950 ()
  • 10887587034768 ()
306795

  • Surgical instrument/implant rack
SCREW PART NUMBER INSERT FOR 401.061-401.065
Synthes GmbH
306.794
In Commercial Distribution

  • H9803067940 ()
  • 10887587034751 ()
306794

  • Surgical instrument/implant rack
SCREW PART NUMBER INSERT FOR 401.041-401.052
Synthes GmbH
306.792
In Commercial Distribution

  • H9803067920 ()
  • 10887587034737 ()
306792

  • Surgical instrument/implant rack
SCREW PART NUMBER INSERT FOR 401.291-401.299
Synthes GmbH
306.791
In Commercial Distribution

  • H9803067910 ()
  • 10887587034720 ()
306791

  • Surgical instrument/implant rack
SCREW PART NUMBER INSERT FOR 401.386-401.398
Synthes GmbH
304.700T35
In Commercial Distribution

  • H980304700T35 ()
  • 10887587031712 ()
304700T35

  • Surgical instrument/implant rack
SCREW PART NUMBER INSERT FOR 401.354-401.374
Synthes GmbH
304.700T27
In Commercial Distribution

  • H980304700T27 ()
  • 10887587031620 ()
304700T27

  • Surgical instrument/implant rack
Valeo TL, System Catalog Number Tag
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555910010024 ()
91.001.0024

  • Instrument tray, reusable
Valeo PL System Catalog Number Tag
AMEDICA CORPORATION
A
In Commercial Distribution

  • M555910040024 ()
91.004.0024

  • Internal spinal fixation procedure kit, single-use
RONGEUR 6 1/2" NUMBER 4A
TELEFLEX INCORPORATED
IPN014157
In Commercial Distribution

  • 24026704274387 ()
  • 04026704274383 ()

  • Length: 16.5 Centimeter
KM47275

  • Orthopaedic joint/limb rongeur
RONGEUR 5 1/2 NUMBER 4
TELEFLEX INCORPORATED
IPN014156
In Commercial Distribution

  • 24026704274370 ()
  • 04026704274376 ()

  • Length: 14 Centimeter
  • Curved 4 x 9MM
KM47274

  • Orthopaedic joint/limb rongeur
MDF PROXIMAL REAMER NUMBER 1 STARTER
Smith & Nephew, Inc.
71354147
Not in Commercial Distribution

  • 00885556023259 ()
71354147

  • Medullary canal orthopaedic reamer, rigid
Part Number 200812, CUFF:INFLATION FOR ROSI
VASCULAR TECHNOLOGY, INCORPORATED
200812
In Commercial Distribution

  • 00817122020430 ()
200812

  • Surgical irrigation/aspiration pump, reusable
Part Number 102200 VTI Oxygen Analyzer
VASCULAR TECHNOLOGY, INCORPORATED
102200
Not in Commercial Distribution

  • 00817122020010 ()
102200

  • Respiratory oxygen monitor, battery-powered
ENDURANCE REVISION CASE & TRAY Number 2
DEPUY ORTHOPAEDICS, INC.
2521-60-004
In Commercial Distribution

  • 10603295128151 ()
252160004

  • Instrument tray, reusable
ENDURANCE REVISION CASE & TRAY Number 1
DEPUY ORTHOPAEDICS, INC.
2521-60-003
In Commercial Distribution

  • 10603295128144 ()
252160003

  • Instrument tray, reusable
BD BACTEC™ Platelet Anaerobic/F Culture Vials
BECTON, DICKINSON AND COMPANY
442054
In Commercial Distribution

  • 30382904420544 ()
  • 00382904420543 ()

  • Total Volume: 40 Milliliter
442054

  • Culture medium antimicrobial supplement IVD
BD BACTEC™ Plus Aerobic/F Medium
BECTON, DICKINSON AND COMPANY
442023
In Commercial Distribution

  • 30382904420230 ()
  • 00382904420239 ()

  • Total Volume: 30 Milliliter
442023

  • Culture medium antimicrobial supplement IVD
Surgical Clipper Charging Adapter
CAREFUSION 2200, INC
5514A
In Commercial Distribution

  • 20885403473200 ()
  • 50885403473201 ()
5514A

  • Noninvasive device battery charger
Surgical Clipper
CAREFUSION 2200, INC
5513E
In Commercial Distribution

  • 20885403473170 ()
  • 50885403473171 ()
5513E

  • Surgical hair clippers
The FIBRINET® System is designed to be used for the safe and rapid preparation of autologous platelet-rich-plasma (PRP) from a small sample of blood at the patient point of care. The PRP is mixed with autograft and/or allograft bone prior to application to a bony defect for improving handling characteristics. The 27 mL FIBRINET® System is available as a single pack (item number 510358) or as a multipack of 5 individually packaged kits (item number 510358-5). The 27 mL FIBRINET® System contains 3 blood collection tubes with yellow stoppers containing buffered sodium citrate solution anticoagulant and plasma separator gel for preparing PRP, 1 PRFM tube containing calcium chloride solution with red stopper, one 30 mL membrane vial with closure containing calcium chloride solution, 1 latex free disposable tourniquet, 2 BD Vacutainer® Luer-Lok™ access devices, 1 BD Vacutainer® blood collection set with Safety-Lok® needle and 12" tubing preassembled, 2 BD Vacutainer® Blood transfer devices, and 1 vial adapter.
ROYAL BIOLOGICS INC.
PRFMK
In Commercial Distribution


  • Total Volume: 27 Milliliter
510358

  • Haematological concentrate system preparation kit, platelet concentration
The FIBRINET® System is designed to be used for the safe and rapid preparation of autologous platelet-rich-plasma (PRP) from a small sample of blood at the patient point of care. The PRP is mixed with autograft and/or allograft bone prior to application to a bony defect for improving handling characteristics. The 27 mL FIBRINET® System is available as a single pack (item number 510358) or as a multipack of 5 individually packaged kits (item number 510358-5). The 27 mL FIBRINET® System contains 3 blood collection tubes with yellow stoppers containing buffered sodium citrate solution anticoagulant and plasma separator gel for preparing PRP, 1 PRFM tube containing calcium chloride solution with red stopper, one 30 mL membrane vial with closure containing calcium chloride solution, 1 latex free disposable tourniquet, 2 BD Vacutainer® Luer-Lok™ access devices, 1 BD Vacutainer® blood collection set with Safety-Lok® needle and 12" tubing preassembled, 2 BD Vacutainer® Blood transfer devices, and 1 vial adapter.
VERTICAL SPINE, LLC
510358
In Commercial Distribution

  • 30851802007077 ()
  • 10851802007073 ()

  • Total Volume: 27 Milliliter
510358

  • Haematological concentrate system preparation kit, platelet concentration
The FIBRINET® System is designed to be used for the safe and rapid preparation of autologous platelet-rich-plasma (PRP) from a small sample of blood at the patient point of care. The PRP is mixed with autograft and/or allograft bone prior to application to a bony defect for improving handling characteristics. The 27 mL FIBRINET® System is available as a single pack (item number 510358) or as a multipack of 5 individually packaged kits (item number 510358-5). The 27 mL FIBRINET® System contains 3 blood collection tubes with yellow stoppers containing buffered sodium citrate solution anticoagulant and plasma separator gel for preparing PRP, 1 PRFM tube containing calcium chloride solution with red stopper, one 30 mL membrane vial with closure containing calcium chloride solution, 1 latex free disposable tourniquet, 2 BD Vacutainer® Luer-Lok™ access devices, 1 BD Vacutainer® blood collection set with Safety-Lok® needle and 12" tubing preassembled, 2 BD Vacutainer® Blood transfer devices, and 1 vial adapter.
ROYAL BIOLOGICS INC.
PRFMK
Not in Commercial Distribution

  • 30850014593019 ()
  • 10850014593022 ()
  • 10851802007073 ()

  • Total Volume: 27 Milliliter
510358

  • Haematological concentrate system preparation kit, platelet concentration
DISPOSABLE HORIZON SUBDERMAL NEEDLE ELECTRODES: 27 GA., 12 MM BENT NEEDLE, 2.3 M (90") SINGLE LEADWIRE, COLOR GROUP C
ROCHESTER ELECTRO-MEDICAL, INC.
S94090-H
Not in Commercial Distribution

  • 10816843022317 ()
  • 10816843022300 ()


  • Subdermal needle electrode
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