AccessGUDID - APP企業簽[電報@S6signi-棋牌企業簽名.whi

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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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

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

Onduo - 00860000249539

Onduo App Android

Company Name: VERILY LIFE SCIENCES LLC

Version or Model: SW0004

Commercial Distribution Status: In Commercial Distribution
Device IDs:

00860000249539 (Primary)

Catalog Number:
GMDN Terms:

Self-care monitoring/reporting software

Onduo - 00860000249522

Onduo App iOS

Company Name: VERILY LIFE SCIENCES LLC

Version or Model: SW0003

Commercial Distribution Status: In Commercial Distribution
Device IDs:

00860000249522 (Primary)

Catalog Number:
GMDN Terms:

Self-care monitoring/reporting software

GN Hearing - 05708296196746

APP,GN SMARTAPP

Company Name: Gn Hearing A/S

Version or Model: 21607300

Commercial Distribution Status: In Commercial Distribution
Device IDs:

05708296196746 (Primary)

Catalog Number:
GMDN Terms:

Hearing aid/implant system remote control

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

SmartView - 08031527019932

SmartView Connect App

Company Name: MICROPORT CRM SRL

Version or Model: SW001U

Commercial Distribution Status: In Commercial Distribution
Device IDs:

08031527019932 (Primary)

Catalog Number: SW001U
GMDN Terms:

Cardiology information system application 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

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