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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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FOP NM-10 is indicated for screening, capture and storage of images of the eye and surrounding area, FOP NM 10 camera is been designed for true colour and monochrome imaging in visible spectrum of light and consists of an incoherent light source. Light from the device is shown into the patient eye & the camera of a smart phone is used to capture images of the eye.
REMIDIO INNOVATIVE SOLUTIONS PRIVATE LIMITED
001
In Commercial Distribution

  • 08906096520014 ()


  • Ophthalmic fundus camera
  • Smartphone camera ophthalmic imaging lens
No Description
CIRCULATORY TECHNOLOGY INC
BB14
In Commercial Distribution

  • 00851997007004 ()

  • Lumen/Inner Diameter: 0.25 Inch
  • Connects to standard 1/4" perfusion tubing connector
BB14

  • Cardiotomy reservoir
Sequential DVT garment
Medhealth Medical Limited
801LSQ
In Commercial Distribution

  • 16975298105199 ()
  • 06975298105192 ()
  • 26975298105196 ()

  • Large, for calf circumference up to 24' (61cm)
801LSQ

  • Intermittent venous compression system
Sequential DVT garment
Medhealth Medical Limited
801MSQ
In Commercial Distribution

  • 16975298105182 ()
  • 06975298105185 ()
  • 26975298105189 ()

  • Medium, for calf circumference up to 18' (45cm)
801MSQ

  • Intermittent venous compression system
WIRE/PIN CUTTER DOUBLE ACTION TUNGSTEN CARBIDE CUTS WIRE UP TO 2.2 MILLIMETERS 30 DEGREE ANGLE QUANTUM
SONTEC INSTRUMENTS, INC.
1103-103VQ
In Commercial Distribution

  • 00192896097179 ()

  • Cuts up to 2.2 Millimeters
  • Length: 8.75 Inch
  • 30 Degree Tip
1103-103VQ

  • Orthopaedic implantable-device cutter
PARALLEL WIRE EXTRACTION PLIERS WITH TUNGSTEN CARBIDE CUTTER RAINBOW COLORED
SONTEC INSTRUMENTS, INC.
1103-126R
In Commercial Distribution

  • 00192896109353 ()

  • Length: 6.5 Inch
  • For Wires up to 1.6 Millimeters in Diameter
1103-126R

  • Wire-extracting pliers
Forehead Oximetry Sensor Headbands
Covidien LP
10004954
In Commercial Distribution

  • 10884521581746 ()
  • 90884521164969 ()
  • 20884521164960 ()

  • Size,greater than or equal to 10,Kilogram;


  • Transcutaneous blood gas monitor sensor
LEWICKY LENS MANIPULATING HOOK BLUNT ANGLED TIP CURVED SHANK
SONTEC INSTRUMENTS, INC.
12-5550
In Commercial Distribution

  • 00192896072848 ()

  • For 0.2 to 0.3 Millimeter Diameter IOL Holes
  • Outer Diameter: 0.15 Millimeter
12-5550

  • Ophthalmic surgical probe, reusable
SINSKEY II LENS MANIPULATING HOOK STRAIGHT BLUNT TIP STAINLESS STEEL
SONTEC INSTRUMENTS, INC.
12-5520
In Commercial Distribution

  • 00192896072831 ()

  • For 0.2 to 0.3 Millimeter Diameter IOL Holes
12-5520

  • Ophthalmic surgical probe, reusable
BIOPSY FORCEPS DOUBLE ACTION VERTICAL OPEN STRAIGHT JAW
SONTEC INSTRUMENTS, INC.
468-370
In Commercial Distribution

  • 00192896040908 ()

  • 90 to 120 Degree Tip
  • 360 Degree Shaft
  • Length: 100 Millimeter
468-370

  • Open-surgery biopsy forceps, reusable
PARALLEL WIRE EXTRACTION PLIERS WITH TUNGSTEN CARBIDE CUTTER
SONTEC INSTRUMENTS, INC.
1103-127
In Commercial Distribution

  • 00192896051560 ()

  • For Wires up to 1.6 Millimeters in Diameter
  • Length: 7.25 Inch
1103-127

  • Wire-extracting pliers
PARALLEL WIRE EXTRACTION PLIERS WITH TUNGSTEN CARBIDE CUTTER
SONTEC INSTRUMENTS, INC.
1103-126
In Commercial Distribution

  • 00192896051553 ()

  • For Wires up to 1.6 Millimeters in Diameter
  • Length: 6.5 Inch
1103-126

  • Wire-extracting pliers
PARALLEL WIRE EXTRACTION PLIERS WITH TUNGSTEN CARBIDE CUTTER
SONTEC INSTRUMENTS, INC.
1103-125
In Commercial Distribution

  • 00192896051546 ()

  • For Wires up to 1.6 Millimeters in Diameter
  • Length: 4.5 Inch
1103-125

  • Wire-extracting pliers
SINSKEY II LENS MANIPULATING HOOK ANGLED BLUNT TIP
SONTEC INSTRUMENTS, INC.
12-5530
In Commercial Distribution

  • 00192896013681 ()

  • For 0.25 to 0.4 Millimeter Diameter IOL Holes
  • Outer Diameter: 0.2 Millimeter
12-5530

  • Ophthalmic surgical probe, reusable
No Description
IMPLANT DIRECT SYBRON MANUFACTURING LLC
1057-30L
Not in Commercial Distribution

  • 10841307115120 ()

  • Emergence: 5.4 flares to 7.3 Platform: 5.7mm Diam
1057-30L

  • Dental implant suprastructure, permanent, preformed
No Description
IMPLANT DIRECT SYBRON MANUFACTURING LLC
1047-30L
Not in Commercial Distribution

  • 10841307115113 ()

  • Emergence: 4.4 flares to 6.3 Platform: 4.7mm Diam
1047-30L

  • Dental implant suprastructure, permanent, preformed
No Description
IMPLANT DIRECT SYBRON MANUFACTURING LLC
1037-30L
Not in Commercial Distribution

  • 10841307115106 ()

  • Emergence: 3.4 flares to 5.3 Platform: 3.7mm Diam
1037-30L

  • Dental implant suprastructure, permanent, preformed
No Description
BIOMET SPINE LLC
07.01721.007
In Commercial Distribution

  • 00889024328884 ()

  • Transverse Connector, Rod to Rod 55 mm W
07.01721.007

  • Bone-screw internal spinal fixation system, non-sterile
No Description
BIOMET SPINE LLC
07.01721.004
In Commercial Distribution

  • 00889024328853 ()

  • Transverse Connector, Rod to Rod 40 mm W
07.01721.004

  • Bone-screw internal spinal fixation system, non-sterile
No Description
BIOMET SPINE LLC
07.01717.003
In Commercial Distribution

  • 00889024328754 ()

  • Transverse Connector, Head to Head 35 mm W
07.01717.003

  • Bone-screw internal spinal fixation system, non-sterile
No Description
Zimmer, Inc.
9366-00-065
Not in Commercial Distribution

  • 00889024181687 ()

  • 1/4 Inch Square Driver to AO Adapter


  • Orthopaedic prosthesis implantation positioning instrument, reusable
A 3-way white stopcock connects to a 12" presure tubing. It includes a separately packed 2x male protective caps.
ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.
687201
In Commercial Distribution

  • 50886333672016 ()
  • 00886333672011 ()

  • 12" Pressure Tubing connected to a 3-way stopcock
687201

  • Invasive blood pressure monitoring tubing set
No Description
CIRCULATORY TECHNOLOGY INC
BBB38
In Commercial Distribution

  • 00851997007011 ()

  • Lumen/Inner Diameter: 0.375 Inch
  • Connects to standard 3/8" perfusion tubing connector
BBB38

  • Cardiotomy reservoir
Young DPA Classic Traditional Web, Firm, Long, White Web Cup, Screw Type
YOUNG DENTAL MANUFACTURING I, LLC
131312
In Commercial Distribution

  • 10302731313129 ()
  • 00302731313122 ()
  • 20302731313126 ()
131312

  • Dental polishing cup, single-use
Young DPA Classic Traditional Web, Soft, Long, Gray Web Cup, Screw Type
YOUNG DENTAL MANUFACTURING I, LLC
131120
Not in Commercial Distribution

  • 10302731311200 ()
  • 00302731311203 ()
  • 20302731311207 ()
131120

  • Dental polishing cup, single-use
Young DPA Classic Traditional Web, Soft, Long, Gray Web Cup, Screw Type
YOUNG DENTAL MANUFACTURING I, LLC
131112
In Commercial Distribution

  • 10302731311125 ()
  • 00302731311128 ()
  • 20302731311122 ()
131112

  • Dental polishing cup, single-use
Tool to be added to implant instrument to increase the length for surgery.
STERNGOLD DENTAL LLC
905280
In Commercial Distribution

  • 00841549118067 ()


  • Surgical screwdriver, reusable
Sirona PC App
DATRIX LLC
Sirona
In Commercial Distribution

  • 00851074007293 ()
RX22773-004

  • Telemetric electrocardiographic ambulatory recorder
Sirona PC App
DATRIX LLC
Sirona
In Commercial Distribution

  • 00851074007255 ()
RX22773-002

  • Telemetric electrocardiographic ambulatory recorder
Sirona PC App
DATRIX LLC
Sirona
In Commercial Distribution

  • 00851074007248 ()
RX22773-001

  • Telemetric electrocardiographic ambulatory recorder
Sirona PC App
DATRIX LLC
Sirona
In Commercial Distribution

  • 00851074007194 ()
RX22773-003

  • Telemetric electrocardiographic ambulatory recorder
Onduo App iOS
VERILY LIFE SCIENCES LLC
SW0003
In Commercial Distribution

  • 00860000249522 ()


  • Self-care monitoring/reporting software
BEYOND app iOS
Widex A/S
BEYOND app
In Commercial Distribution

  • 05706069659689 ()
5 300 0003 001

  • Hearing aid enhanced audio device, telecommunication/multimedia
COM-DEX app iOS
Widex A/S
COM-DEX APP
In Commercial Distribution

  • 05706069599978 ()
5 300 0000 001

  • Hearing aid enhanced audio device, telecommunication/multimedia
Patient Controller App
ST. JUDE MEDICAL, INC.
55500
In Commercial Distribution

  • 05415067034977 ()
55500

  • Multiple active implantable device programmer
Clinician Programmer App
ST. JUDE MEDICAL, INC.
55600
In Commercial Distribution

  • 05415067034960 ()
55600

  • Multiple active implantable device programmer
Patient Controller App
ADVANCED NEUROMODULATION SYSTEMS, INC.
3871
Not in Commercial Distribution

  • 05415067023810 ()
3871

  • Multiple active implantable device programmer
Clinician Programmer App
ADVANCED NEUROMODULATION SYSTEMS, INC.
3870
Not in Commercial Distribution

  • 05415067023803 ()
3870

  • Multiple active implantable device programmer
Digital Health App
ADVANCED NEUROMODULATION SYSTEMS, INC.
3876
In Commercial Distribution

  • 05415067050311 ()
3876

  • Multiple active implantable device programmer
Viewfinder remote app
Edwards Lifesciences LLC
VFREM
In Commercial Distribution

  • 00690103215847 ()
VFREM

  • Bedside monitor remote-viewing software, physiological parameter
  • General-purpose multi-parameter bedside monitor
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