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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CPR faceshield with one way valve
B.L.S. Systems Limited
2030
In Commercial Distribution

  • B00220300 ()
  • B00220305 ()
2030

  • Cardiopulmonary resuscitation mask, single-use
One Step Custom Kit Micro-Introducer 6F
ARGON MEDICAL DEVICES, INC.
497864
Not in Commercial Distribution

  • 10886333215338 ()
  • 00886333215331 ()
  • 20886333215335 ()

  • 6F
497864

  • Vascular catheter introduction set, nonimplantable
9F One Piece/Tuohy-Borst Catheter Introducer
ARGON MEDICAL DEVICES, INC.
496136
In Commercial Distribution

  • 10886333213631 ()
  • 00886333213634 ()
  • 20886333213638 ()

  • 9F
496136

  • Vascular catheter introduction set, nonimplantable
8.5F One Piece/Tuohy-Borst Catheter Introducer
ARGON MEDICAL DEVICES, INC.
496135
In Commercial Distribution

  • 10886333213624 ()
  • 00886333213627 ()
  • 20886333213621 ()

  • 8.5F
496135

  • Vascular catheter introduction set, nonimplantable
8F One Piece/Tuohy-Borst Catheter Introducer
ARGON MEDICAL DEVICES, INC.
496134
In Commercial Distribution

  • 10886333213617 ()
  • 00886333213610 ()
  • 20886333213614 ()

  • 8F
496134

  • Vascular catheter introduction set, nonimplantable
6F One Piece/Tuohy-Borst Catheter Introducer
ARGON MEDICAL DEVICES, INC.
496132
In Commercial Distribution

  • 10886333213594 ()
  • 00886333213597 ()
  • 20886333213591 ()

  • 6F
496132

  • Vascular catheter introduction set, nonimplantable
One Step Micro Introducer System 4F
ARGON MEDICAL DEVICES, INC.
497821
Not in Commercial Distribution

  • 10886333222282 ()
  • 00886333222285 ()
  • 20886333222289 ()

  • 4F
497821

  • Vascular catheter introduction set, nonimplantable
ONE PIECE 9MM END CUTTING REAMER
Smith & Nephew, Inc.
E0015581-1
In Commercial Distribution

  • 00885556697276 ()
E0015581-1

  • Medullary canal orthopaedic reamer, rigid
ONE PIECE DESIGN C-ARM DRP, 1-EACH
Microtek Medical LLC
1
In Commercial Distribution

  • 30748426005513 ()
  • 00748426005512 ()
  • 50748426005517 ()


  • Instrument/equipment drape, single-use, sterile
All In One Stylet, Extra-Short, Sterile
SPINEOLOGY INC.
67-23-10-5
In Commercial Distribution

  • M7406700076 ()
670-0076

  • Orthopaedic intraoperative positioning pin, single-use
All In One Stylet, Short, Non-Sterile
SPINEOLOGY INC.
67-23-10-2
In Commercial Distribution

  • M7406700071 ()
670-0071

  • Surgical drill guide, reusable
All In One Stylet, Long, Non-Sterile
SPINEOLOGY INC.
67-23-10-1
In Commercial Distribution

  • M7406700070 ()
670-0070

  • Surgical drill guide, reusable
HOSE, INTERCONNECTING, LFA-110 POINT ONE, 1-EACH
Microtek Medical LLC
1
In Commercial Distribution

  • 50748426090766 ()
  • 00748426090761 ()


  • Surgical fluid/smoke waste management system suction unit
INTRODUCER ONE STEP 4FR X 45CM
STRADIS MEDICAL, LLC
525-029
Not in Commercial Distribution

  • M7525250292 ()
  • M7525250291 ()

  • Length: 45 Centimeter
  • Catheter Gauge: 4 French
525-029

  • Vascular catheter introduction set, nonimplantable
FILTER, EXTERNAL DISPOSABLE POINT ONE, 1-EACH
Microtek Medical LLC
1
In Commercial Distribution

  • 50748426097000 ()
  • 00748426112982 ()


  • Surgical fluid/smoke waste management system suction unit
Rampart One 28 cm Trial Inserter
SPINEOLOGY INC.
102-53-01
In Commercial Distribution

  • M7401021292 ()

  • Length: 28 Centimeter
102-1292

  • Surgical implant/trial-implant/sizer holder, reusable
Rampart One Trial, 14mm, L, 8°
SPINEOLOGY INC.
49-02-01-21
In Commercial Distribution

  • M7404902021 ()

  • Large Footprint
  • 8° Lordosis
  • Height: 14 Millimeter
490-2021

  • Polymeric spinal fusion cage, sterile
Rampart One Trial, 12mm, L, 8°
SPINEOLOGY INC.
49-02-01-20
In Commercial Distribution

  • M7404902020 ()

  • Height: 12 Millimeter
  • 8° Lordosis
  • Large Footprint
490-2020

  • Polymeric spinal fusion cage, sterile
Rampart One Trial, 16mm, M, 12°
SPINEOLOGY INC.
49-02-01-17
In Commercial Distribution

  • M7404902017 ()

  • Height: 16 Millimeter
  • 12° Lordosis
  • Medium Footprint
490-2017

  • Polymeric spinal fusion cage, sterile
Rampart One Trial, 14mm, M, 12°
SPINEOLOGY INC.
49-02-01-16
In Commercial Distribution

  • M7404902016 ()

  • Medium Footprint
  • 12° Lordosis
  • Height: 14 Millimeter
490-2016

  • Polymeric spinal fusion cage, sterile
Rampart One Trial, 12mm, M, 12°
SPINEOLOGY INC.
49-02-01-15
In Commercial Distribution

  • M7404902015 ()

  • Height: 12 Millimeter
  • 12° Lordosis
  • Medium Footprint
490-2015

  • Polymeric spinal fusion cage, sterile
Rampart One Trial, 16mm, M, 8°
SPINEOLOGY INC.
49-02-01-13
In Commercial Distribution

  • M7404902013 ()

  • Medium Footprint
  • 8° Lordosis
  • Height: 16 Millimeter
490-2013

  • Polymeric spinal fusion cage, sterile
Rampart One Trial, 14mm, M, 8°
SPINEOLOGY INC.
49-02-01-12
In Commercial Distribution

  • M7404902012 ()

  • Height: 14 Millimeter
  • 8° Lordosis
  • Medium Footprint
490-2012

  • Polymeric spinal fusion cage, sterile
Rampart One Trial, 12mm, M, 8°
SPINEOLOGY INC.
49-02-01-11
In Commercial Distribution

  • M7404902011 ()

  • Medium Footprint
  • 8° Lordosis
  • Height: 12 Millimeter
490-2011

  • Polymeric spinal fusion cage, sterile
Rampart One Trial, 10.5mm, M, 8°
SPINEOLOGY INC.
49-02-01-10
In Commercial Distribution

  • M7404902010 ()

  • Height: 10.5 Millimeter
  • 8° Lordosis
  • Medium Footprint
490-2010

  • Polymeric spinal fusion cage, sterile
Rampart One Trial, 14mm, S, 12°
SPINEOLOGY INC.
49-02-01-7
In Commercial Distribution

  • M7404902007 ()

  • Height: 14 Millimeter
  • 12° Lordosis
  • Small Footprint
490-2007

  • Polymeric spinal fusion cage, sterile
Rampart One Trial, 12mm, S, 12°
SPINEOLOGY INC.
49-02-01-6
In Commercial Distribution

  • M7404902006 ()

  • Small Footprint
  • 12° Lordosis
  • Height: 12 Millimeter
490-2006

  • Polymeric spinal fusion cage, sterile
Rampart One Trial, 14mm, S, 8°
SPINEOLOGY INC.
49-02-01-3
In Commercial Distribution

  • M7404902003 ()

  • Small Footprint
  • 8° Lordosis
  • Height: 14 Millimeter
490-2003

  • Polymeric spinal fusion cage, sterile
Rampart One Trial, 12mm, S, 8°
SPINEOLOGY INC.
49-02-01-2
In Commercial Distribution

  • M7404902002 ()

  • Height: 12 Millimeter
  • 8° Lordosis
  • Small Footprint
490-2002

  • Polymeric spinal fusion cage, sterile
Rampart One Trial, 10.5mm, S, 8°
SPINEOLOGY INC.
49-02-01-1
In Commercial Distribution

  • M7404902001 ()

  • Small Footprint
  • 8° Lordosis
  • Height: 10.5 Millimeter
490-2001

  • Polymeric spinal fusion cage, sterile
Rampart One Trial, 18mm, M, 12°
SPINEOLOGY INC.
49-02-01-34
In Commercial Distribution

  • M7404902034 ()

  • 12° Lordosis
  • Medium Footprint
  • Height: 18 Millimeter
490-2034

  • Polymeric spinal fusion cage, sterile
Rampart One Trial, 18mm, M, 20°
SPINEOLOGY INC.
49-02-01-33
In Commercial Distribution

  • M7404902033 ()

  • 20° Lordosis
  • Medium Footprint
  • Height: 18 Millimeter
490-2033

  • Polymeric spinal fusion cage, sterile
Rampart One Trial, 18mm, M, 16°
SPINEOLOGY INC.
49-02-01-32
In Commercial Distribution

  • M7404902032 ()

  • Height: 18 Millimeter
  • Medium Footprint
  • 16° Lordosis
490-2032

  • Polymeric spinal fusion cage, sterile
Rampart One Trial, 16mm, M, 20°
SPINEOLOGY INC.
49-02-01-31
In Commercial Distribution

  • M7404902031 ()

  • Height: 16 Millimeter
  • Medium Footprint
  • 20° Lordosis
490-2031

  • Polymeric spinal fusion cage, sterile
Rampart One Trial, 16mm, M, 16°
SPINEOLOGY INC.
49-02-01-30
In Commercial Distribution

  • M7404902030 ()

  • 16° Lordosis
  • Medium Footprint
  • Height: 16 Millimeter
490-2030

  • Polymeric spinal fusion cage, sterile
Rampart One Trial, 14mm, M, 16°
SPINEOLOGY INC.
49-02-01-29
In Commercial Distribution

  • M7404902029 ()

  • Height: 14 Millimeter
  • Medium Footprint
  • 16° Lordosis
490-2029

  • Polymeric spinal fusion cage, sterile
Rampart One Trial, 16mm, L, 12°
SPINEOLOGY INC.
49-02-01-26
In Commercial Distribution

  • M7404902026 ()

  • Large Footprint
  • 12° Lordosis
  • Height: 16 Millimeter
490-2026

  • Polymeric spinal fusion cage, sterile
Rampart One Trial, 14mm, L, 12°
SPINEOLOGY INC.
49-02-01-25
In Commercial Distribution

  • M7404902025 ()

  • Height: 14 Millimeter
  • 12° Lordosis
  • Large Footprint
490-2025

  • Polymeric spinal fusion cage, sterile
Rampart One Trial, 12mm, L, 12°
SPINEOLOGY INC.
49-02-01-24
In Commercial Distribution

  • M7404902024 ()

  • Large Footprint
  • 12° Lordosis
  • Height: 12 Millimeter
490-2024

  • Polymeric spinal fusion cage, sterile
Rampart One Trial, 16mm, L, 8°
SPINEOLOGY INC.
49-02-01-22
In Commercial Distribution

  • M7404902022 ()

  • Height: 16 Millimeter
  • 8° Lordosis
  • Large Footprint
490-2022

  • Polymeric spinal fusion cage, sterile
3.5MM HEX HEAD SCREWDRIVER ONE PIECE
Smith & Nephew, Inc.
E0017128-1
In Commercial Distribution

  • 00885556794470 ()
E0017128-1

  • Surgical screwdriver, reusable
Surgical Gown_Non-Reinforced_W/ one hand towle_XL_Non-Sterile_32ea/cs
GRI Medical & Electronic Technology Co., Ltd.
60300456
In Commercial Distribution

  • 06931918157071 ()
  • 16931918157078 ()


  • Surgical gown, single-use
Surgical Gown_Non-Reinforced_XL_W/ one hand towel_Sterile_28EA/CS
GRI Medical & Electronic Technology Co., Ltd.
GH90-8030-S1
In Commercial Distribution

  • 26931918152117 ()
  • 16931918152110 ()


  • Surgical gown, single-use
Surgical Gown_i500_Non-Reinforced_XXL_W/ one hand towel_Sterile_26EA/CS
GRI Medical & Electronic Technology Co., Ltd.
i90-8040-S1
In Commercial Distribution

  • 26931918150694 ()
  • 16931918150697 ()


  • Surgical gown, single-use
Surgical Gown_i500_Non-Reinforced_XL_W/ one hand towel_Sterile_28EA/CS
GRI Medical & Electronic Technology Co., Ltd.
SF90-8030-S1
In Commercial Distribution

  • 26931918144761 ()
  • 16931918144764 ()


  • Surgical gown, single-use
Surgical Gown_Non-Reinforced_W/ one hand towle_S_Non-Sterile_28ea/cs
GRI Medical & Electronic Technology Co., Ltd.
60300469
In Commercial Distribution

  • 06931918142770 ()
  • 16931918142777 ()


  • Surgical gown, single-use
Surgical Gown_Non-Reinforced_L_W/ one hand towel_Sterile_30EA/CS
GRI Medical & Electronic Technology Co., Ltd.
90-8020-S1
In Commercial Distribution

  • 26931918139354 ()
  • 16931918139357 ()


  • Surgical gown, single-use
Surgical Gown_Non-Reinforced_W/ one hand towle_M_Non-Sterile_36ea/cs
GRI Medical & Electronic Technology Co., Ltd.
60300454
In Commercial Distribution

  • 06931918127258 ()
  • 16931918127255 ()


  • Surgical gown, single-use
Surgical Gown_Non-Reinforced_W/ one hand towle_L_Non-Sterile_36ea/cs
GRI Medical & Electronic Technology Co., Ltd.
60300455
In Commercial Distribution

  • 06931918137400 ()
  • 16931918137407 ()


  • Surgical gown, single-use
Surgical Gown_i500_Non-Reinforced_XL_W/ one hand towel_Sterile_28EA/CS
GRI Medical & Electronic Technology Co., Ltd.
i90-8030-S1
In Commercial Distribution

  • 26931918131877 ()
  • 16931918131870 ()


  • Surgical gown, single-use
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