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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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AIR-FLOW-PIEZON - 07613353060510

Multifunction foot pedal
E.M.S. Electro Medical Systems S.A.
B
In Commercial Distribution

  • 07613353060510 ()
EK-169#A/005

  • Foot-switch, electrical

AIR-FLOW - 07613353050900

Update Kit Air Flow Handpiece
E.M.S. Electro Medical Systems S.A.
b
In Commercial Distribution

  • 07613353050900 ()
EQ-160

  • Dental abrasive air jet system

AIR-FLOW - 07613353046682

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

  • 07613353046682 ()
EL-540#A/003

  • Dental abrasive air jet system handpiece

PIEZON - 07613353030797

Set of Files
E.M.S. Electro Medical Systems S.A.
b
In Commercial Distribution

  • 07613353030797 ()
DT-011

  • Ultrasonic dental scaling/debridement system handpiece tip, periodontal

PIEZON - 07613353030780

Tube of 6 files ISO 35 (Green)
E.M.S. Electro Medical Systems S.A.
b
In Commercial Distribution

  • 07613353030780 ()

  • Outer Diameter: 0.35 Millimeter
DT-010

  • Ultrasonic dental scaling/debridement system handpiece tip, periodontal

PIEZON - 07613353030773

Tube of 6 files ISO 30 (Blue)
E.M.S. Electro Medical Systems S.A.
b
In Commercial Distribution

  • 07613353030773 ()

  • Outer Diameter: 0.30 Millimeter
DT-009

  • Ultrasonic dental scaling/debridement system handpiece tip, periodontal

PIEZON - 07613353030766

Tube of 6 files ISO 25 (Red)
E.M.S. Electro Medical Systems S.A.
b
In Commercial Distribution

  • 07613353030766 ()

  • Outer Diameter: 0.25 Millimeter
DT-008

  • Ultrasonic dental scaling/debridement system handpiece tip, periodontal

PIEZON - 07613353030759

Tube of 6 files ISO 20 (Yellow)
E.M.S. Electro Medical Systems S.A.
b
In Commercial Distribution

  • 07613353030759 ()

  • Outer Diameter: 0.20 Millimeter
DT-007

  • Ultrasonic dental scaling/debridement system handpiece tip, periodontal

PIEZON - 07613353030742

Tube of 6 files ISO 15 (White)
E.M.S. Electro Medical Systems S.A.
b
In Commercial Distribution

  • 07613353030742 ()

  • Outer Diameter: 0.15 Millimeter
DT-006

  • Ultrasonic dental scaling/debridement system handpiece tip, periodontal

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

AIR-FLOW-PIEZON - 07613353002732

AIR-FLOW S2
E.M.S. Electro Medical Systems S.A.
b
Not in Commercial Distribution

  • 07613353002732 ()
FT-178HF

  • Ultrasonic dental scaling/debridement system
  • Dental abrasive air jet system

AIR-FLOW-PIEZON - 07613353002725

AIR-FLOW S2 basic
E.M.S. Electro Medical Systems S.A.
b
In Commercial Distribution

  • 07613353002725 ()
FT-178HF/HF

  • Ultrasonic dental scaling/debridement system
  • Dental abrasive air jet system

AIR-FLOW - 07613353002718

AIR-FLOW S1
E.M.S. Electro Medical Systems S.A.
b
Not in Commercial Distribution

  • 07613353002718 ()
FT-177HF

  • Dental abrasive air jet system

PIEZON - 07613353002589

Perio Basic System
E.M.S. Electro Medical Systems S.A.
b
In Commercial Distribution

  • 07613353002589 ()
FS-343

  • Ultrasonic dental scaling/debridement system

AIR-FLOW - 07613353002480

PERIO-FLOW Handpiece White
E.M.S. Electro Medical Systems S.A.
B
In Commercial Distribution

  • 07613353002480 ()
EL-354HF/C

  • Dental abrasive air jet system

AIR-FLOW - 07613353002473

AIR-FLOW Handpiece White at 120°
E.M.S. Electro Medical Systems S.A.
B
In Commercial Distribution

  • 07613353002473 ()
EL-308HF/C

  • Dental abrasive air jet system

AIR-FLOW-PIEZON - 07613353002404

Basic Air-Flow Master Piezon
E.M.S. Electro Medical Systems S.A.
b
In Commercial Distribution

  • 07613353002404 ()
FT-200HF/HF

  • Dental abrasive air jet system
  • Ultrasonic dental scaling/debridement system

AIR-FLOW-PIEZON - 07613353002398

AIR-FLOW MASTER PIEZON System White
E.M.S. Electro Medical Systems S.A.
b
In Commercial Distribution

  • 07613353002398 ()
FS-338HF/C

  • Ultrasonic dental scaling/debridement system
  • Dental abrasive air jet system

AIR-FLOW - 07613353002374

40 PERIO-FLOW nozzles
E.M.S. Electro Medical Systems S.A.
b
In Commercial Distribution

  • 07613353002374 ()
  • 07613353002435 ()
DT-113HF

  • Dental abrasive air jet system

LITHOCLAST - 07613353001964

Ultrasound Probe Ø 3.3 x 403mm
E.M.S. Electro Medical Systems S.A.
B
In Commercial Distribution

  • 07613353001964 ()
FR-084

  • Ultrasonic lithotripsy system probe, reusable

LITHOCLAST - 07613353001940

Ultrasound Probe Ø 3.3 x 403mm
E.M.S. Electro Medical Systems S.A.
B
In Commercial Distribution

  • 07613353001940 ()
FR-083

  • Ultrasonic lithotripsy system probe, reusable

PIEZON - 07613353001773

The Piezon handpiece is an accessory in the Piezo-ceramic systems for dentistry.
E.M.S. Electro Medical Systems S.A.
B
In Commercial Distribution

  • 07613353001773 ()
EN-046HF

  • Ultrasonic dental scaling/debridement system

LithoClast - 07613353001247

Suction tube Ø1,6x595mm (4,8 Ch.)
E.M.S. Electro Medical Systems S.A.
B
In Commercial Distribution

  • 07613353001247 ()
EL-213

  • Pneumatic/ultrasonic lithotripsy system

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

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

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

EPIC FRACTURE PLATE SYSTEM - 00817577023628

Left Lateral Fibula Plate - Xlong
Exactech, Inc.
B
In Commercial Distribution

  • 00817577023628 ()
2000-7011

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile

EPIC FRACTURE PLATE SYSTEM - 00817577023611

Left Lateral Fibula Plate - Long
Exactech, Inc.
B
In Commercial Distribution

  • 00817577023611 ()
2000-7010

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile

EPIC FRACTURE PLATE SYSTEM - 00817577023604

Left Lateral Fibula Plate - STD
Exactech, Inc.
B
In Commercial Distribution

  • 00817577023604 ()
2000-7009

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile

EPIC FRACTURE PLATE SYSTEM - 00817577023598

Right Lateral Fibula Plate - XLong
Exactech, Inc.
B
In Commercial Distribution

  • 00817577023598 ()
2000-7008

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile

EPIC FRACTURE PLATE SYSTEM - 00817577023581

Right Lateral Fibula Plate - Long
Exactech, Inc.
B
In Commercial Distribution

  • 00817577023581 ()
2000-7007

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile

EPIC FRACTURE PLATE SYSTEM - 00817577023574

Right Lateral Fibula Plate - Std
Exactech, Inc.
B
In Commercial Distribution

  • 00817577023574 ()
2000-7006

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile

EPIC FRACTURE PLATE SYSTEM - 00817577023567

Universal Lateral Fibula Plate - XLong
Exactech, Inc.
B
In Commercial Distribution

  • 00817577023567 ()
2000-7005

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile

EPIC FRACTURE PLATE SYSTEM - 00817577023550

Universal Lateral Fibula Plate - Long
Exactech, Inc.
B
In Commercial Distribution

  • 00817577023550 ()
2000-7004

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile

EPIC FRACTURE PLATE SYSTEM - 00817577023543

No Description
Exactech, Inc.
B
In Commercial Distribution

  • 00817577023543 ()
2000-7003

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile

EPIC SMALL STAPLE - 00817577023147

Small Staple
Exactech, Inc.
B
In Commercial Distribution

  • 00817577023147 ()
3000-1010

  • Orthopaedic bone staple, non-adjustable, non-sterile

EPIC FOOT PLATE SYSTEM - 00817577023123

No Description
Exactech, Inc.
B
In Commercial Distribution

  • 00817577023123 ()
2000-5003

  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile

EPIC FOOT PLATE SYSTEM - 00817577022379

No Description
Exactech, Inc.
B
In Commercial Distribution

  • 00817577022379 ()
2000-6004

  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile

EPIC FOOT PLATE SYSTEM - 00817577022362

No Description
Exactech, Inc.
B
In Commercial Distribution

  • 00817577022362 ()
2000-6003

  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile

EPIC FOOT PLATE SYSTEM - 00817577022355

No Description
Exactech, Inc.
B
In Commercial Distribution

  • 00817577022355 ()
2000-6002

  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile

EPIC FOOT PLATE SYSTEM - 00817577022348

No Description
Exactech, Inc.
B
In Commercial Distribution

  • 00817577022348 ()
2000-6001

  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile

EPIC FOOT PLATE SYSTEM - 00817577022331

No Description
Exactech, Inc.
B
In Commercial Distribution

  • 00817577022331 ()
2000-6000

  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile

EPIC FOOT PLATE SYSTEM - 00817577022324

No Description
Exactech, Inc.
B
In Commercial Distribution

  • 00817577022324 ()
2000-5002

  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile

EPIC FOOT PLATE SYSTEM - 00817577022317

No Description
Exactech, Inc.
B
In Commercial Distribution

  • 00817577022317 ()
2000-5001

  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile
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