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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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
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
3.5MM HEX HEAD SCREWDRIVER ONE PIECE
Smith & Nephew, Inc.
E0017884-1
In Commercial Distribution

  • 00885556889688 ()
E0017884-1

  • Surgical screwdriver, reusable
3.5MM HEX HEAD SCREWDRIVER ONE PIECE
Smith & Nephew, Inc.
E0017128-1
In Commercial Distribution

  • 00885556794470 ()
E0017128-1

  • Surgical screwdriver, reusable
ONE PIECE 9MM END CUTTING REAMER
Smith & Nephew, Inc.
E0015581-1
In Commercial Distribution

  • 00885556697276 ()
E0015581-1

  • Medullary canal orthopaedic reamer, rigid
MOBILE ANEROID W ONE PIECE CUFF
WELCH ALLYN, INC.
901091
In Commercial Distribution

  • 00732094046755 ()
407637

  • Aneroid manual sphygmomanometer
One box with 2 vials strip
BIONIME CORPORATION
Max Strip
In Commercial Distribution

  • 20883489001744 ()
  • 10883489001747 ()
  • 00883489001740 ()
  • 00883489001733 ()
  • 80883489001739 ()


  • Glucose monitoring system IVD, home-use
RALLY ALL IN ONE CEMENT GUN
Smith & Nephew, Inc.
71271610
In Commercial Distribution

  • 00885556582275 ()
71271610

  • Orthopaedic cement/bone filler dispensing gun
Semi kit: one blood glucose meter
EPS BIO TECHNOLOGY CORP.
EMMU
In Commercial Distribution

  • 01885017000101 ()
  • 00885017000102 ()
  • 10885017000109 ()


  • Glucose monitoring system IVD, home-use
Semi kit: one blood glucose meter
EPS BIO TECHNOLOGY CORP.
EMMU
In Commercial Distribution

  • 00885017000065 ()
  • 01885017000064 ()
  • 10885017000062 ()


  • Glucose monitoring system IVD, home-use
One Super Sensitive 3 pack (LTS)
GLOBAL PROTECTION CORP.
GC11603
In Commercial Distribution

  • 80726893118207 ()
  • 00726893118201 ()


  • Basic male condom, Hevea-latex
ONE Pleasure Plus Bowl of 100
GLOBAL PROTECTION CORP.
14000B
In Commercial Distribution

  • 80726893115220 ()
  • 00726893115224 ()


  • Basic male condom, Hevea-latex
ONE Glowing Pleasures Bowl of 100
GLOBAL PROTECTION CORP.
11500B
In Commercial Distribution

  • 80726893115190 ()
  • 00726893115194 ()


  • Basic male condom, Hevea-latex
ONE Color Sensations Bowl of 100
GLOBAL PROTECTION CORP.
11100B
In Commercial Distribution

  • 80726893115183 ()
  • 00726893115187 ()


  • Basic male condom, Hevea-latex
ONE Flavor Waves bowl of 100
GLOBAL PROTECTION CORP.
110200B
In Commercial Distribution

  • 80726893113929 ()
  • 00726893113923 ()


  • Basic male condom, Hevea-latex
One Super Sensitive Bowl of 100
GLOBAL PROTECTION CORP.
11600B
In Commercial Distribution

  • 80726893112519 ()
  • 00726893112513 ()


  • Basic male condom, Hevea-latex
ONE Mixed Pleasures USA 24-Pack Piece
GLOBAL PROTECTION CORP.
110104
In Commercial Distribution

  • 80726893110249 ()
  • 00726893110243 ()
  • 20726893110247 ()


  • Basic male condom, Hevea-latex
ONE® Oasis Silk 2oz Tube
GLOBAL PROTECTION CORP.
11L401
In Commercial Distribution

  • 00726893210158 ()
  • 20726893210152 ()


  • Sexual lubricant
3.5MM HEX HEAD SCREWDRIVER ONE PIECE
Smith & Nephew, Inc.
E0016721-1
In Commercial Distribution

  • 00885556768877 ()
E0016721-1

  • Surgical screwdriver, reusable
One Piece™ Implant CA Driver
INTRA-LOCK INTERNATIONAL, INC.
OPCAD
In Commercial Distribution

  • D742OPCAD0 ()
OPCAD

  • Dental implant system
LHK, US,ONE LEGACY TISSUE SERV
MEDLINE INDUSTRIES, INC.
VASC1468
In Commercial Distribution

  • 40195327535965 ()
  • 10195327535964 ()
VASC1468

  • General surgical procedure kit, non-medicated, single-use
Basic Chest Drainage Unit,One Chamber
Cardinal Health, Inc.
8884713100
In Commercial Distribution

  • 00884521067298 ()
  • 00884521128319 ()

  • Total Volume: 2000 Milliliter
8884713100

  • Autotransfusion system blood collection container
7 Panel One Step DOA Cup
BTNX Inc
D7.3-1V
In Commercial Distribution

  • 00722066004630 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
TAUT SYSTEM ONE TITANIUM4 WIRE BASKET
TELEFLEX INCORPORATED
IPN007724
In Commercial Distribution

  • 24026704418880 ()

  • Width: 15 Millimeter
  • Length: 100 Centimeter
50024

  • Laparoscopic access cannula, single-use
Devon Magnetic Drape One Neutral Zone
Cardinal Health 200, LLC
31159703
In Commercial Distribution

  • 10192253021585 ()
  • 50192253021583 ()
31159703

  • Medical equipment/instrument drape, single-use
Inogen One G4 Oxygen Concentrator (10-06530-XX-XX)
Inogen, Inc.
630
In Commercial Distribution

  • 00817131020117 ()
IO-400

  • Mobile/portable oxygen concentrator
Inogen One G3 Oxygen Concentrator (10-06124-XX-XX)
Inogen, Inc.
1050
In Commercial Distribution

  • 00817131020063 ()
IO-300

  • Mobile/portable oxygen concentrator
Inogen One G3 Oxygen Concentrator (10-06124-XX-XX)
Inogen, Inc.
1050
In Commercial Distribution

  • 00817131020056 ()
IO-300

  • Mobile/portable oxygen concentrator
Inogen One G3 Oxygen Concentrator (10-03500-XX-XX)
Inogen, Inc.
840
In Commercial Distribution

  • 00817131020049 ()
IO-300

  • Mobile/portable oxygen concentrator
Inogen One G3 Oxygen Concentrator (10-03500-XX-XX)
Inogen, Inc.
840
In Commercial Distribution

  • 00817131020032 ()
IO-300

  • Mobile/portable oxygen concentrator
Inogen One G2 Oxygen Concentrator (10-04779-XX-XX)
Inogen, Inc.
1260
In Commercial Distribution

  • 00817131020025 ()
IO-200

  • Mobile/portable oxygen concentrator
Inogen One G2 Oxygen Concentrator (10-04779-XX-XX)
Inogen, Inc.
1260
In Commercial Distribution

  • 00817131020018 ()
IO-200

  • Mobile/portable oxygen concentrator
Reline One Power Instrument Set - Alpha
Nuvasive, Inc.
ALPRELONEPOWIN
In Commercial Distribution

  • 00195377098450 ()


  • Device sterilization/disinfection container, reusable
Alpha Reline One Polyaxial Imp Tray
Nuvasive, Inc.
ALPRELONEPOLY
In Commercial Distribution

  • 00195377050236 ()


  • Device sterilization/disinfection container, reusable
Alpha Reline One Modular Imp Tray
Nuvasive, Inc.
ALPRELONEMOD
In Commercial Distribution

  • 00195377050229 ()


  • Internal spinal fixation procedure kit, reusable
MOD-EX XLIF Inserter, All In One
Nuvasive, Inc.
D1970000
In Commercial Distribution

  • 00195377043511 ()


  • Internal spinal fixation procedure kit, reusable
Introducer Sheath System containing One (1) introducer Sheath with haemostasis valve and One (1) dilator.
Contract Medical International GmbH
7F; 45 cm; crossover
In Commercial Distribution

  • 14251244503779 ()
  • 04251244503772 ()

  • Length: 45 Centimeter
  • Lumen/Inner Diameter: 2.55 Millimeter
452386

  • Vascular catheter introduction set, nonimplantable
Introducer Sheath System containing One (1) introducer Sheath with haemostasis valve and One (1) dilator.
Contract Medical International GmbH
7F; 45 cm; straight
In Commercial Distribution

  • 14251244503755 ()
  • 04251244503758 ()

  • Length: 45 Centimeter
  • Lumen/Inner Diameter: 2.55 Millimeter
452382

  • Vascular catheter introduction set, nonimplantable
Introducer Sheath System containing One (1) introducer Sheath with haemostasis valve and One (1) dilator.
Contract Medical International GmbH
6F; 90 cm; straight
In Commercial Distribution

  • 14251244503748 ()
  • 04251244503741 ()

  • Length: 90 Centimeter
  • Lumen/Inner Diameter: 2.20 Millimeter
444481

  • Vascular catheter introduction set, nonimplantable
Introducer Sheath System containing One (1) introducer Sheath with haemostasis valve and One (1) dilator.
Contract Medical International GmbH
6F; 65 cm; straight
In Commercial Distribution

  • 14251244503731 ()
  • 04251244503734 ()

  • Length: 65 Centimeter
  • Lumen/Inner Diameter: 2.20 Millimeter
444482

  • Vascular catheter introduction set, nonimplantable
Introducer Sheath System containing One (1) introducer Sheath with haemostasis valve and One (1) dilator.
Contract Medical International GmbH
5F, 90cm, straight, firm
In Commercial Distribution

  • 14251244501096 ()
  • 04251244501099 ()
  • 24251244501093 ()

  • Length: 90 Centimeter
  • Lumen/Inner Diameter: 1.92 Millimeter
FG-05090-F

  • Vascular catheter introduction set, nonimplantable
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