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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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Taurus Pedicle Screw System - M555513045060

Taurus Pedicle Screw System- Screw, Pedicle TL 4.5x60mm
AMEDICA CORPORATION
B
Not in Commercial Distribution

  • M555513045060 ()

  • Length: 60 Millimeter
  • Outer Diameter: 4.5 Millimeter
51-3045-060

  • Spinal bone screw, non-bioabsorbable

Taurus Pedicle Screw System - M555513045055

Taurus Pedicle Screw System- Screw, Pedicle TL 4.5x55mm
AMEDICA CORPORATION
B
Not in Commercial Distribution

  • M555513045055 ()

  • Outer Diameter: 4.5 Millimeter
  • Length: 55 Millimeter
51-3045-055

  • Spinal bone screw, non-bioabsorbable

Taurus Pedicle Screw System - M555513045045

N/A
AMEDICA CORPORATION
B
Not in Commercial Distribution

  • M555513045045 ()

  • Outer Diameter: 4.5 Millimeter
  • Length: 45 Millimeter
51-3045-045

  • Bone-screw internal spinal fixation system, non-sterile

FUSION Silane - D8370620100

A two-part silane system creating a stronger chemical bond to feldspathic porcelain, all ceramic restorations, and recommended for best adhesion to veneers, crowns and other ceramic restorations. Also use it for easy chair-side repairs to: porcelain-gold restorations, porcelain jackets, porcelain denture teeth, popped-out porcelain veneers or facings. Eliminates costly laboratory remakes. This non-toxic, non-irritating formula can be used in or out of the mouth.
Taub Products
B
In Commercial Distribution

  • D8370620100 ()

  • Total Volume: 6 Milliliter
06-2010

  • Dental repair kit, ceramic

Merit Advance® - 10884450846664

No Description
Merit Medical Systems, Inc.
B
In Commercial Distribution

  • 20884450846661 ()
  • 10884450846664 ()
  • 00884450846667 ()

  • Accepts Guide Wire-0.038" (0.97 mm)
  • Gauge-18G
  • Length (cm)-7.0 cm
SL18T71W

  • General surgical procedure kit, non-medicated, single-use
  • Basic intravenous administration set, noninvasive

Merit Advance® - 10884450830779

No Description
Merit Medical Systems, Inc.
B
In Commercial Distribution

  • 20884450830776 ()
  • 10884450830779 ()
  • 00884450830772 ()

  • Accepts Guide Wire-0.038" (0.97 mm)
  • Length (cm)-7.0 cm
  • Gauge-18G
SL18T71WS

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

SAFEGUARD FOCUS™ - 10884450828745

No Description
Merit Medical Systems, Inc.
B
In Commercial Distribution

  • 00884450828748 ()
  • 10884450828745 ()

  • Band Length-17 cm
SGF1A

  • Pressure bandage, non-latex, single-use

SAFEGUARD® - 10884450758721

No Description
Merit Medical Systems, Inc.
B
In Commercial Distribution

  • 20884450758728 ()
  • 10884450758721 ()
  • 00884450758724 ()

  • Band Length-24 cm
SG2440AC

  • Femoral artery compression system, manual, single-use

Merit Medical® - 10884450628307

No Description
ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.
B
In Commercial Distribution

  • 20884450628304 ()
  • 10884450628307 ()
  • 00884450628300 ()

  • Length-25 cm
682106

  • Invasive blood pressure monitoring tubing set

PreludeSYNC DISTAL™ - 10884450574383

No Description
Merit Medical Systems, Inc.
B
In Commercial Distribution

  • 00884450574386 ()
  • 10884450574383 ()

  • Size (Volume)-10 mL
SDRB10AC

  • Radial artery compression device

TEMNO® - 10884450444631

No Description
Merit Medical Systems, Inc.
B
In Commercial Distribution

  • 20884450444638 ()
  • 10884450444631 ()
  • 00884450444634 ()

  • Biopsy Device Length (cm)-15.0 cm
  • Biopsy Device Gauge-20G
T2015

  • Soft-tissue biopsy procedure kit, non-medicated

Meritrans DTXPlus® - 10884450360634

No Description
ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.
B
In Commercial Distribution

  • 20884450360631 ()
  • 10884450360634 ()
  • 00884450360637 ()
682001

  • Invasive blood pressure transducer set

TEMNO Evolution® - 10884450443504

No Description
Merit Medical Systems, Inc.
B
In Commercial Distribution

  • 20884450443501 ()
  • 10884450443504 ()
  • 00884450443507 ()

  • Biopsy Device Gauge-14G
  • Biopsy Device Length (cm)-20.0 cm
TT1420

  • Soft-tissue biopsy procedure kit, non-medicated

High Density Junction Box - B - 00850011306383

Passive adapter with touchproof inputs and a high density output for adapting 3rd party electrode interface cables to the ATLAS Neurophysiology System. Version "B" is labeled for connections to electrodes 65-128.
NEURALYNX, INC.
-B
In Commercial Distribution

  • 00850011306383 ()
31-0602-0034

  • Electrical-only medical device connection cable, reusable

Lara Docking Station - 00850014578107

No Description
LUCERNO DYNAMICS, LLC
B
In Commercial Distribution

  • 00850014578251 ()
  • 00850014578107 ()
401874-285

  • Scintillation-counter radiation survey meter

Lara Reader - 00850014578008

No Description
LUCERNO DYNAMICS, LLC
B
In Commercial Distribution

  • 00850014578169 ()
  • 00850014578008 ()
401874-230

  • Scintillation-counter radiation survey meter

SuperBall - 00850000630017

The SuperBall Meniscal Repair System is a single patient, single use, an all-inside, all-suture meniscal repair device.
ARCURO MEDICAL LTD
B
In Commercial Distribution

  • 00850000630017 ()
SBD-SB-12-001

  • Polyester suture, non-bioabsorbable, multifilament

AIR-FLOW - 07613353223939

AIR-FLOW Handpiece handy 2+ 120°
E.M.S. Electro Medical Systems S.A.
B
In Commercial Distribution

  • 07613353223939 ()
EL-185#C/013

  • Dental abrasive air jet system handpiece

AIR-FLOW - 07613353223793

AIR-FLOW® handy 3.0 PERIO
E.M.S. Electro Medical Systems S.A.
B
In Commercial Distribution

  • 07613353223793 ()
FT-221#NA/006

  • Dental abrasive air jet system handpiece

PIEZON - 07613353223069

PIEZON 250
E.M.S. Electro Medical Systems S.A.
B
In Commercial Distribution

  • 07613353223069 ()
FT-224#C/011

  • Ultrasonic dental scaling/debridement system

PIEZON - 07613353222710

PIEZON 250
E.M.S. Electro Medical Systems S.A.
B
In Commercial Distribution

  • 07613353222710 ()
FT-224#C/009

  • Ultrasonic dental scaling/debridement system

PIEZON - 07613353198183

PIEZON 150
E.M.S. Electro Medical Systems S.A.
B
In Commercial Distribution

  • 07613353198183 ()
FT-215#C/004

  • Ultrasonic dental scaling/debridement system

PIEZON - 07613353196127

PIEZON 150
E.M.S. Electro Medical Systems S.A.
B
In Commercial Distribution

  • 07613353196127 ()
FT-215#C/003

  • Ultrasonic dental scaling/debridement system

PIEZON - 07613353195724

PIEZON 150
E.M.S. Electro Medical Systems S.A.
B
In Commercial Distribution

  • 07613353195724 ()
FT-215#C/002

  • Ultrasonic dental scaling/debridement system

PIEZON - 07613353192631

PIEZON 150
E.M.S. Electro Medical Systems S.A.
B
In Commercial Distribution

  • 07613353192631 ()
FT-215#C/001

  • Ultrasonic dental scaling/debridement system

AIR-FLOW - 07613353170424

Air-Flow Handy Perio Handpiece
E.M.S. Electro Medical Systems S.A.
B
In Commercial Distribution

  • 07613353170424 ()
EL-352#C/003

  • Dental abrasive air jet system

PIEZON - 07613353169602

Installation Kit PiezoLED
E.M.S. Electro Medical Systems S.A.
B
In Commercial Distribution

  • 07613353169602 ()
FS-349

  • Ultrasonic dental scaling/debridement system

PIEZON - 07613353169572

Handpiece KaVo PiezoSOFT
E.M.S. Electro Medical Systems S.A.
B
In Commercial Distribution

  • 07613353169572 ()
EN-072#A

  • Ultrasonic dental scaling/debridement system

AIR-FLOW - 07613353168537

AIR-FLOW® PLUS handy 3.0 PERIO handpiece
E.M.S. Electro Medical Systems S.A.
B
In Commercial Distribution

  • 07613353168537 ()
EL-545/A

  • Dental abrasive air jet system handpiece

AIR-FLOW - 07613353168520

AIR-FLOW Handy 3.0 Handpiece
E.M.S. Electro Medical Systems S.A.
B
In Commercial Distribution

  • 07613353168520 ()
EL-542/A

  • Dental abrasive air jet system handpiece

PIEZON - 07613353167844

PIEZON MASTER 700
E.M.S. Electro Medical Systems S.A.
B
In Commercial Distribution

  • 07613353167844 ()
FT-194#HF/A/001

  • Ultrasonic dental scaling/debridement system

PIEZON - 07613353167837

PIEZON MASTER 700
E.M.S. Electro Medical Systems S.A.
B
In Commercial Distribution

  • 07613353167837 ()
FT-194#HF/A

  • Ultrasonic dental scaling/debridement system

AIR-FLOW - 07613353167820

AIR-FLOW MASTER Perio
E.M.S. Electro Medical Systems S.A.
B
In Commercial Distribution

  • 07613353167820 ()
FT-188#HF/A/001

  • Dental abrasive air jet system

AIR-FLOW - 07613353167813

AIR-FLOW MASTER Perio
E.M.S. Electro Medical Systems S.A.
B
In Commercial Distribution

  • 07613353167813 ()
FT-188#HF/A

  • Dental abrasive air jet system

LITHOCLAST - 07613353151843

Pneumatic handpiece pn3 kit
E.M.S. Electro Medical Systems S.A.
B
In Commercial Distribution

  • 07613353151843 ()
FR-089#A/001

  • Pneumatic lithotripsy system handpiece

PIEZON - 07613353132804

Piezon Handpiece
E.M.S. Electro Medical Systems S.A.
B
In Commercial Distribution

  • 07613353132804 ()
EN-061HF

  • Ultrasonic dental scaling/debridement system

PIEZON - 07613353112318

PIEZON 250
E.M.S. Electro Medical Systems S.A.
B
Not in Commercial Distribution

  • 07613353112318 ()
FT-216/HF

  • Ultrasonic dental scaling/debridement system

PIEZON - 07613353101039

CombiTorque
E.M.S. Electro Medical Systems S.A.
B
In Commercial Distribution

  • 07613353101039 ()
FV-060

  • Ultrasonic dental scaling/debridement system handpiece tip, periodontal

LITHOCLAST - 07613353062309

Probe Ø 2 x 425 mm (6,0 Ch.)
E.M.S. Electro Medical Systems S.A.
B
In Commercial Distribution

  • 07613353062309 ()
EL-044#A/004

  • Pneumatic lithotripsy system probe, urinary

PIEZON MASTER SURGERY - 07613353029791

Instrument SL1 with Surgery CT
E.M.S. Electro Medical Systems S.A.
B
In Commercial Distribution

  • 07613353029791 ()
DS-101B

  • Dental ultrasonic surgical system handpiece tip
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