AccessGUDID - app超級簽名銷售經理電報yoernet）.asa

GUDID

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

Pressure,30-40 mmHg (3)
9x12mm (2)
12 Blocks, 3 Firing Pads, 1 Syr. Calibra Ceram w/10 mix tips, 1 bottle Prime&Bond elect, 25 flocked app. tips, 1 disp. well, 1 syr. Coupling Agent w/25 disp. app. needles, 1 Stain & Glaze Kit (1)
2 Tooth Colored Syringes, 2 Blue Syringes, 1 bottle each Xeno®, P&B, and activator, 25 Mixing Tips, 25 Intraoral Tips, 10 Endo Intaoral Tips, 1 Disp Well, 50 App Tips, 50 Root Canal Tips (1)
20 Compula® Tips-5 each shade A1, A2, A3, A3.5 (0.25g each), 20 Adhesive Unit Doses, 1 Syringe Tooth Cond Gel, 1 Compules® Tips Gun, 1 Unit Dose Holder, 25 App Needles, 50 App Tips (1)
5 Syringes Cement, 5 Syringes Try-In Paste, 1 Bottle Adhesive, 1 Dispensing Well, 50 Tips, 1 Light Protection Cover, 1 Syringe Silane Coupling Agent, 1 Syringe Tooth Cond Gel, 25 App Needles (1)
6 Compules® Tips, 1 Compules® Tips Gun, 3 Compula® Tips, Enhance® Finishers, 6 Bond Unit Doses, 1 Unit Dose Holder, 6 Flocked Applicator Tips, 1 Syringe Tooth Cond Gel, 25 App Tips (1)
8 TPH3 Syringes, 5 P&B Unit Doses, 1 Prisma Gloss Fine and Extrafine Syringe, 1 syringe Tooth Cond Gel, 1 shade guide, 25 polishing cups, 1 mandrel, Enhance Discs, Cups, & Points, 5 App Tips (1)
No size - Software as a Medical Device (1)
SIZE 2, TYPE 0 (1)
UNIV (1)
Ø5.8X4.0(2.0)mm (1)

Device Class

Implantable

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Cardiostaff - 00851074007194

Sirona PC App

Company Name: DATRIX LLC

Version or Model: Sirona

Commercial Distribution Status: In Commercial Distribution
Device IDs:

00851074007194 (Primary)

Catalog Number: RX22773-003
GMDN Terms:

Telemetric electrocardiographic ambulatory recorder

Cardiostaff - 00851074007170

Sirona Android App

Company Name: DATRIX LLC

Version or Model: Sirona

Commercial Distribution Status: In Commercial Distribution
Device IDs:

00851074007170 (Primary)

Catalog Number: RX22711-003
GMDN Terms:

Telemetric electrocardiographic ambulatory recorder

CardioLabs - 00851074007248

Sirona PC App

Company Name: DATRIX LLC

Version or Model: Sirona

Commercial Distribution Status: In Commercial Distribution
Device IDs:

00851074007248 (Primary)

Catalog Number: RX22773-001
GMDN Terms:

Telemetric electrocardiographic ambulatory recorder

Widex - 05706069599985

COM-DEX app Android

Company Name: Widex A/S

Version or Model: COM-DEX APP

Commercial Distribution Status: In Commercial Distribution
Device IDs:

05706069599985 (Primary)

Catalog Number: 5 300 0001 001
GMDN Terms:

Hearing aid enhanced audio device, telecommunication/multimedia

Widex - 05706069659689

BEYOND app iOS

Company Name: Widex A/S

Version or Model: BEYOND app

Commercial Distribution Status: In Commercial Distribution
Device IDs:

05706069659689 (Primary)

Catalog Number: 5 300 0003 001
GMDN Terms:

Hearing aid enhanced audio device, telecommunication/multimedia

Widex - 05706069599978

COM-DEX app iOS

Company Name: Widex A/S

Version or Model: COM-DEX APP

Commercial Distribution Status: In Commercial Distribution
Device IDs:

05706069599978 (Primary)

Catalog Number: 5 300 0000 001
GMDN Terms:

Hearing aid enhanced audio device, telecommunication/multimedia

hear.com - 05714880113228

APP HEAR.COM HORIZON

Company Name: Ws Audiology Usa, Inc.

Version or Model: hear.com horizon

Commercial Distribution Status: In Commercial Distribution
Device IDs:

05714880113228 (Primary)

Catalog Number: 10996569
GMDN Terms:

Hearing aid/implant system remote control

CONNEXX - 05714880187229

APP CONNEXX FIT2GO

Company Name: Ws Audiology Usa, Inc.

Version or Model: Connexx Fit2Go

Commercial Distribution Status: In Commercial Distribution
Device IDs:

05714880187229 (Primary)

Catalog Number: 21023158
GMDN Terms:

Audiometric/hearing device software

NeuroSphere™ - 05415067050311

Digital Health App

Company Name: ADVANCED NEUROMODULATION SYSTEMS, INC.

Version or Model: 3876

Commercial Distribution Status: In Commercial Distribution
Device IDs:

05415067050311 (Primary)

Catalog Number: 3876
GMDN Terms:

Multiple active implantable device programmer

Viewfinder remote app - 00690103215847

Viewfinder remote app

Company Name: Edwards Lifesciences LLC

Version or Model: VFREM

Commercial Distribution Status: In Commercial Distribution
Device IDs:

00690103215847 (Primary)

Catalog Number: VFREM
GMDN Terms:

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

PMI Probasics® - 00841447104070

APP (Pads only)

Company Name: COMPASS HEALTH BRANDS CORP.

Version or Model: SA901P

Commercial Distribution Status: Not in Commercial Distribution
Device IDs:

00841447104070 (Primary)

Catalog Number: SA901P
GMDN Terms:

Air-filled bed mattress overlay

mySCS™ GO - 00191506020705

Therapy Controller App

Company Name: BOSTON SCIENTIFIC NEUROMODULATION CORPORATION

Version or Model: SC-5275

Commercial Distribution Status: In Commercial Distribution
Device IDs:

00191506020705 (Primary)

Catalog Number:
GMDN Terms:

Implantable spinal cord electrical stimulation system programmer

UbiqVue - B353UA2251R1

Holter Mobile App

Company Name: Lifesignals, Inc.

Version or Model: UA2251-R

Commercial Distribution Status: In Commercial Distribution
Device IDs:

B353UA2251R1 (Primary)

Catalog Number:
GMDN Terms:

Medical equipment clinical data interfacing software

Eloquence - 00816486021237

Eloquence iOS App

Company Name: PRENTKE ROMICH COMPANY

Version or Model: Eloquence App

Commercial Distribution Status: In Commercial Distribution
Device IDs:

00816486021237 (Primary)

Catalog Number: 19683
GMDN Terms:

Voice synthesizer/digitizer

PRC-Saltillo - 00816486021183

Dialogue AAC App

Company Name: PRENTKE ROMICH COMPANY

Version or Model: Dialogue App

Commercial Distribution Status: In Commercial Distribution
Device IDs:

00816486021183 (Primary)

Catalog Number: 18312
GMDN Terms:

Voice synthesizer/digitizer

Saltillo - 00816486021053

TouchChat HD App

Company Name: PRENTKE ROMICH COMPANY

Version or Model: TouchChat App

Commercial Distribution Status: In Commercial Distribution
Device IDs:

00816486021053 (Primary)

Catalog Number: 18626-4
GMDN Terms:

Voice synthesizer/digitizer

Saltillo - 00816486021022

Classic TouchChat App

Company Name: PRENTKE ROMICH COMPANY

Version or Model: TouchChat App

Commercial Distribution Status: In Commercial Distribution
Device IDs:

00816486021022 (Primary)

Catalog Number: 18626-0
GMDN Terms:

Voice synthesizer/digitizer

Sonova Brand - 07613389477191

myPhonak Junior app

Company Name: Sonova AG

Version or Model: 088-0017-71

Commercial Distribution Status: In Commercial Distribution
Device IDs:

07613389477191 (Primary)

Catalog Number: 088-0017-71
GMDN Terms:

Audiometric/hearing device software

Sonova Brand - 07613389477177

myPhonak Junior app

Company Name: Sonova AG

Version or Model: 088-0017-22

Commercial Distribution Status: In Commercial Distribution
Device IDs:

07613389477177 (Primary)

Catalog Number: 088-0017-22
GMDN Terms:

Audiometric/hearing device software

Sonova Brand - 07613389477153

myPhonak Junior app

Company Name: Sonova AG

Version or Model: 088-0017-06

Commercial Distribution Status: In Commercial Distribution
Device IDs:

07613389477153 (Primary)

Catalog Number: 088-0017-06
GMDN Terms:

Audiometric/hearing device software

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