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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Eyeglass Frame,"Fortuna,Midnight,55"
ENCORE VISION, INC.
Fortuna
In Commercial Distribution

  • 00812056032429 ()


  • Prescription spectacles
Eyeglass Frame,"Fortuna,Gold,55"
ENCORE VISION, INC.
Fortuna
In Commercial Distribution

  • 00812056032412 ()


  • Prescription spectacles
Eyeglass Frame,"Fortuna,Chocolate,55"
ENCORE VISION, INC.
Fortuna
In Commercial Distribution

  • 00812056032405 ()


  • Prescription spectacles
Eyeglass Frame,"Florin,Rose,52"
ENCORE VISION, INC.
Florin
In Commercial Distribution

  • 00812056032399 ()


  • Prescription spectacles
Eyeglass Frame,"Florin,Lilac,52"
ENCORE VISION, INC.
Florin
In Commercial Distribution

  • 00812056032382 ()


  • Prescription spectacles
Eyeglass Frame,"Florin,Almond,52"
ENCORE VISION, INC.
Florin
In Commercial Distribution

  • 00812056032375 ()


  • Prescription spectacles
Eyeglass Frame,"Dinero,Matte Black,55"
ENCORE VISION, INC.
Dinero
In Commercial Distribution

  • 00812056032368 ()


  • Prescription spectacles
Eyeglass Frame,"Dinero,Matte Navy,55"
ENCORE VISION, INC.
Dinero
In Commercial Distribution

  • 00812056032351 ()


  • Prescription spectacles
Eyeglass Frame,"Dinero,Brushed Silver,55"
ENCORE VISION, INC.
Dinero
In Commercial Distribution

  • 00812056032344 ()


  • Prescription spectacles
Eyeglass Frame,"CC700, Purple, 54-18-135"
ENCORE VISION, INC.
CC700
In Commercial Distribution

  • 00812056032337 ()


  • Prescription spectacles
Eyeglass Frame,"CC700, Brown, 54-18-135"
ENCORE VISION, INC.
CC700
In Commercial Distribution

  • 00812056032320 ()


  • Prescription spectacles
Rod to Rod Clamp, 5.5mm to 6.5mm
GLOBUS MEDICAL, INC.
154.862
In Commercial Distribution

  • 00849044004830 ()

  • Length: 8 Millimeter


  • Trans-facet-screw internal spinal fixation system, sterile
Rod to Rod Clamp, 5.5mm to 5.5mm
GLOBUS MEDICAL, INC.
124.962
In Commercial Distribution

  • 00849044002799 ()

  • Width: 8 Millimeter


  • Trans-facet-screw internal spinal fixation system, sterile
Rotation Socket, to clamp to OR table
Karl Storz GmbH & Co. KG
28172HR
In Commercial Distribution

  • 04048551107546 ()
28172HR

  • Surgical instrument assist arm system, manually-adjusted
Socket, to clamp to the OR table
Karl Storz GmbH & Co. KG
28172HK
In Commercial Distribution

  • 04048551107539 ()
28172HK

  • Surgical instrument assist arm system, manually-adjusted
Motor To Angle Adapter to Fit STAR
Vector R&D, Inc.
CA-ST
In Commercial Distribution

  • 00810113690704 ()
CA-ST

  • Dental power tool handpiece motorless component
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
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
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
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
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
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
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
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
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
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
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
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
The Huma platform is a modular Software as a Medical Device (SaMD) which may utilise compatible devices and software to obtain data collated via a mobile app or web app and delivered to the clinician via a web portal or web app where it may be viewed to drive clinical management. It is intended to be used for the physiological and non-physiological intermittent or spot-check monitoring of all condition patients in professional healthcare facilities, such as clinics, hospitals or skilled nursing facilities, or in the patient’s home setting. It is intended for the monitoring of patients by trained healthcare professionals. The Huma platform comprises a number of different modules and functionalities that can be selected by the customer for configuration of care plans which can be further personalised for the patients. Clinical information collected from these modules is displayed on a clinician web portal and patient app with the addition of flagging out of range datasets, trend visualisation, goal setting and communication channels between clinicians and patients.
MedoPad Inc.
1.34
In Commercial Distribution

  • G2871002 ()
1002

  • Self-care monitoring/reporting software
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
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
Software as a medical device (SaMD) for some Lilly medicines which provides access to medication reminders and customer support services; Operates on Android devices (various manufacturers)
ELI LILLY AND COMPANY
MA9141 Android (Version 17)
In Commercial Distribution

  • 00300021458553 ()
MA9141001AM

  • Medication reminder application software
  • Patient subjective symptom recorder
Software as a medical device (SaMD) for some Lilly medicines which provides access to medication reminders and customer support services; Operates on Apple iOS devices
ELI LILLY AND COMPANY
MA9142 IOS (Version 17)
In Commercial Distribution

  • 00300021451554 ()
MA9142001AM

  • Medication reminder application software
  • Patient subjective symptom recorder
Software as a medical device (SaMD) for some Lilly medicines which provides access to medication reminders and customer support services; Operates on Apple iOS devices
ELI LILLY AND COMPANY
MA9162 IOS (Version 15)
In Commercial Distribution

  • 00300021286552 ()
MA9162001AM

  • Medication reminder application software
  • Patient subjective symptom recorder
Software as a medical device (SaMD) for some Lilly medicines which provides access to medication reminders and customer support services; Operates on Android devices (various manufacturers)
ELI LILLY AND COMPANY
MA9161 Android (Version 15)
In Commercial Distribution

  • 00300021285555 ()
MA9161001AM

  • Medication reminder application software
  • Patient subjective symptom recorder
Software as a medical device (SaMD) for some Lilly medicines which provides access to medication reminders and customer support services; Operates on Apple iOS devices
ELI LILLY AND COMPANY
MA9160 IOS (Version 14)
In Commercial Distribution

  • 00300021284558 ()
MA9160001AM

  • Medication reminder application software
  • Patient subjective symptom recorder
Software as a medical device (SaMD) for some Lilly medicines which provides access to medication reminders and customer support services; Operates on Android devices (various manufacturers)
ELI LILLY AND COMPANY
MA9159 Android (Version 14)
In Commercial Distribution

  • 00300021283551 ()
MA9159001AM

  • Medication reminder application software
  • Patient subjective symptom recorder
Software as a medical device (SaMD) for some Lilly medicines which provides access to medication reminders and customer support services; Operates on Apple iOS devices
ELI LILLY AND COMPANY
MA9158 IOS (Version 13)
In Commercial Distribution

  • 00300021177553 ()
MA9158001AM

  • Medication reminder application software
  • Patient subjective symptom recorder
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