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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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N/A - 00763000273668

SW APP A71100 SCS RESTORE CLINICIAN
MEDTRONIC, INC.
A71100
In Commercial Distribution

  • 00763000273668 ()


  • Multiple active implantable device programmer

N/A - 00763000159092

SW APP A52200 GU PATIENT PERFICIO
MEDTRONIC, INC.
A52200
In Commercial Distribution

  • 00763000159092 ()


  • Multiple active implantable device programmer

N/A - 00763000159085

SW APP A51200 GU CLINICIAN PERFICIO
MEDTRONIC, INC.
A51200
In Commercial Distribution

  • 00763000159085 ()


  • Multiple active implantable device programmer

Guardian™ Connect App - 00763000158392

SFTWR CSS7200 GRDN IOS APP V3.2.1
MEDTRONIC MINIMED, INC.
CSS7200
In Commercial Distribution

  • 00763000158392 ()


  • Patient health record information system application software

StealthStation Cranial Software - 00763000125295

SFW 9735762 APP STEALTH S8 APPLICATION
MEDTRONIC NAVIGATION, INC.
9735762
In Commercial Distribution

  • 00763000125295 ()


  • Multi-purpose stereotactic surgery system

N/A - 00763000024024

SW APP A520 GU PATIENT CHRONIC
MEDTRONIC, INC.
A520
In Commercial Distribution

  • 00763000024024 ()


  • Multiple active implantable device programmer

N/A - 00763000024017

SW APP A510 GU CLINICIAN CHRONIC
MEDTRONIC, INC.
A510
In Commercial Distribution

  • 00763000024017 ()


  • Multiple active implantable device programmer

StealthStation - 00763000063177

SFW 9735762 APP STEALTH S8 APPLICATION
MEDTRONIC NAVIGATION, INC.
9735762
In Commercial Distribution

  • 00763000063177 ()


  • Multi-purpose stereotactic surgery system

SonoNav™ - 00721902865565

SFTWR 9730780 KIT SONONAV APP - PLUS
MEDTRONIC NAVIGATION, INC.
9730780
In Commercial Distribution

  • 00721902865565 ()


  • Multi-purpose stereotactic surgery system

N/A - 00721902865558

SFTWR 9730897 KIT FUNCTIONAL APP - PLUS
MEDTRONIC NAVIGATION, INC.
9730897
In Commercial Distribution

  • 00721902865558 ()


  • Multi-purpose stereotactic surgery system

FrameLink™ - 00721902966460

SFTWR 9731128 KIT, FRAMELINK APP -PLUS
MEDTRONIC NAVIGATION, INC.
9731128
In Commercial Distribution

  • 00721902966460 ()


  • Multi-purpose stereotactic surgery system

Dario LC Blood Glucose Monitoring System & Dario Membership - 00850065006451

The Dario LC Blood Glucose Monitoring System is a compact, all-in-one blood glucose meter that is used in conjunction with a smart mobile device (SMD). The Dario LC meter is connected to a SMD through an Apple Lightning® connector in order to provide the glucose meter with power. The SMD also provides an external display for the user to review blood glucose testing results via a mobile application downloaded to the SMD. The full process of blood glucose measurement is done on the glucose meter; the SMD does not provide any diagnostic or clinical analysis function. When connected to a SMD, the Dario LC glucose meter is agnostic both to the platform of the smart mobile device and to the model of the individual SMD within a platform. Dario LC Blood Glucose Monitoring System & Dario Membership includes 50 Dario Blood Glucose Test Strips. Dario Blood Glucose Test Strips are for use with the Dario Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip.
LABSTYLE INNOVATION LTD
1183-05
In Commercial Distribution

  • 00850065006451 ()


  • Glucose monitoring system IVD, home-use
  • Glucose IVD, kit, enzyme spectrophotometry, rapid

3M™ Unitek™ - 00652221110930

3M™ Unitek™ Prestige How Utility Pliers, Regular Tip, 900-701, 1/Ea
3M UNITEK CORPORATION
900-702
In Commercial Distribution

  • 00652221110930 ()
900-702

  • Orthodontic pliers

3M™ Unitek™ - 00652221110947

3M™ Unitek™ Prestige How Utility Pliers, Os Tip, 900-702, 1/Ea
3M UNITEK CORPORATION
900-703
In Commercial Distribution

  • 00652221110947 ()
900-703

  • Orthodontic pliers

INTEGRA - 00650551146766

INTEGRA, HOW HEIGHT BE SHAPE, ENHANCED SURFACE, SINGLE STAGE, INTERNAL PORT TISSUE EXPANDER
PMT CORPORATION
3611ES-13-IR
In Commercial Distribution

  • 00650551146766 ()

  • Total Volume: 430 Milliliter
  • Length: 13 Centimeter
  • Width: 11 Centimeter


  • Skin-port tissue expander

Balt Aspiration Tubing Set - 00810068563986

The Balt Aspiration Tubing Set is intended to connect the Raptor Aspiration Catheter to the canister of a compatible aspiration pump and to allow the user to control the fluid flow.
BALT USA LLC
BASPT-110
In Commercial Distribution

  • 00810068563986 ()

  • Length: 114”
  • Inner Diameter: 0.110” ± 0.003”
N/A

  • Thrombectomy suction catheter

BlackBox RPM - B963BPM201W1

Blood Pressure monitor designed to be used seamlessly with our proprietary hub or mobile app.
Blackbox Remote Patient Monitoring LLC
BPM-201W
Not in Commercial Distribution

  • B963BPM201W1 ()
  • BB1BB963201W1 ()


  • Automatic-inflation electronic sphygmomanometer, portable, arm/wrist

Clue Conceive - 04260749840022

Clue Conceive is a mode of the Clue app. Clue Conceive's proprietary algorithm uses period start date information entered by the user to provide predictions on the best days to try and conceive. Identification of high chance days allows the user to determine the days on which their chance of conception is highest, and then make choices about when to have sex to increase chance of pregnancy.
BioWink GmbH
Android
In Commercial Distribution

  • 04260749840022 ()


  • Self-care monitoring/reporting software

Clue Conceive - 04260749840015

Clue Conceive is a mode of the Clue app. Clue Conceive's proprietary algorithm uses period start date information entered by the user to provide predictions on the best days to try and conceive. Identification of high chance days allows the user to determine the days on which their chance of conception is highest, and then make choices about when to have sex to increase chance of pregnancy.
BioWink GmbH
iOS
In Commercial Distribution

  • 04260749840015 ()


  • Self-care monitoring/reporting software

Ozeri - 00815817014153

The Thermometer can display the result in either Fahrenheit or degree Celsius. Colour - Black How to use: Steady and smoothly scroll the wheel either back and fourth or in one direction, so as to travel 12 inches or 30 cm. The scrolling will kinetically charge the device. Continue scroll the wheel until the LCD ON. Position the thermometer at the distance of less than 1 inch for the center of the patients eyebrows. Press and release the measure button.
COMMONPATH LLC
TH1-BL
In Commercial Distribution

  • 10815817014150 ()
  • 00815817014153 ()
  • 20815817014157 ()


  • Infrared patient thermometer, ear

Ozeri - 00815817013484

The Thermometer can display the result in either Fahrenheit or degree Celsius. How to use: Steady and smoothly scroll the wheel either back and fourth or in one direction, so as to travel 12 inches or 30 cm. The scrolling will kinetically charge the device. Continue scroll the wheel until the LCD ON. Position the thermometer at the distance of less than 1 inch for the center of the patients eyebrows. Press and release the measure button.
COMMONPATH LLC
TH1-W
In Commercial Distribution

  • 10815817013481 ()
  • 00815817013484 ()
  • 20815817013488 ()
NT1

  • Infrared patient thermometer, ear

Ref-Keratometer HRK-1 - 08800019600480

The Ref/Keratometer is intended to be used to measure the refractive power of the eye
Huvitz Co., Ltd.
HRK-1
In Commercial Distribution

  • 08800019600480 ()
HRK-1

  • Ophthalmic refractometer, manual

Ref/Keratometers HRK-7000 - 08800019600138

The Ref/Keratometer is intended to be used to measure the refractive power of the eye
Huvitz Co., Ltd.
HRK-7000
In Commercial Distribution

  • 08800019600138 ()
HRK-7000

  • Ophthalmic refractometer, manual

Protective Vest No Sleeve - M1435040070

The Vest Holder is intended to be used to limit the movement of the patient's body.
Kenad SG Medical, Inc.
Protective Vest No Sleeve Xlarge
Not in Commercial Distribution

  • M1435040070 ()
50-4007

  • Limb/torso/head restraint, single-use

Protective Vest No Sleeve - M1435040060

The Vest Holder is intended to be used to limit the movement of the patient's body.
Kenad SG Medical, Inc.
Protective Vest No Sleeve Large
Not in Commercial Distribution

  • M1435040060 ()
50-4006

  • Limb/torso/head restraint, single-use

Protective Vest No Sleeve - M1435040050

The Vest Holder is intended to be used to limit the movement of the patient's body.
Kenad SG Medical, Inc.
Protective Vest No Sleeve Medium
Not in Commercial Distribution

  • M1435040050 ()
50-4005

  • Limb/torso/head restraint, single-use

Protective Vest No Sleeve - M1435040040

The Vest Holder is intended to be used to limit the movement of the patient's body.
Kenad SG Medical, Inc.
Protective Vest No Sleeve Small
Not in Commercial Distribution

  • M1435040040 ()
50-4004

  • Limb/torso/head restraint, single-use

Universal Waist Holder - M1435036000

The waist holder is intended to be used to limit the movement of the patient's body.
Kenad SG Medical, Inc.
Patient Protective Waist Holder w/slit
Not in Commercial Distribution

  • M1435036000 ()
50-3600

  • Limb/torso/head restraint, single-use

Universal Waist Holder - M1435035000

The waist holder is intended to be used to limit the movement of the patient's body.
Kenad SG Medical, Inc.
Patient Protective Waist Holder Adult
Not in Commercial Distribution

  • M1435035000 ()
50-3500

  • Limb/torso/head restraint, single-use

Universal Waist Holder - M1435034000

The Waist Holder is intended to be used to limit the movement of the patient's body.
Kenad SG Medical, Inc.
Universal Waist Holder Pediatric
Not in Commercial Distribution

  • M1435034000 ()
50-3400

  • Limb/torso/head restraint, single-use
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