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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Omnipod 5 Controller APP - 10385081120302

Actual downloadable APP, called Omnipod 5 Controller APP

Company Name: Insulet Corporation

Version or Model: 1.0

Commercial Distribution Status: In Commercial Distribution
Device IDs:

10385081120302 (Primary)

Catalog Number:
GMDN Terms:

Ambulatory insulin infusion pump/interstitial glucose monitoring system

N/A - 00763000523329

SW APP A620 DBS PATIENT APP V3.0 LK55

Company Name: MEDTRONIC, INC.

Version or Model: A620

Commercial Distribution Status: In Commercial Distribution
Device IDs:

00763000523329 (Primary)

Catalog Number:
GMDN Terms:

Multiple active implantable device programmer

N/A - 00763000523312

SW APP A610 DBS CLINICIAN APP V4.0 LK54

Company Name: MEDTRONIC, INC.

Version or Model: A610

Commercial Distribution Status: In Commercial Distribution
Device IDs:

00763000523312 (Primary)

Catalog Number:
GMDN Terms:

Multiple active implantable device programmer

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

NA - 05415067034977

Patient Controller App

Company Name: ST. JUDE MEDICAL, INC.

Version or Model: 55500

Commercial Distribution Status: In Commercial Distribution
Device IDs:

05415067034977 (Primary)

Catalog Number: 55500
GMDN Terms:

Multiple active implantable device programmer

NA - 05415067034960

Clinician Programmer App

Company Name: ST. JUDE MEDICAL, INC.

Version or Model: 55600

Commercial Distribution Status: In Commercial Distribution
Device IDs:

05415067034960 (Primary)

Catalog Number: 55600
GMDN Terms:

Multiple active implantable device programmer

SJM™ - 05415067023810

Patient Controller App

Company Name: ADVANCED NEUROMODULATION SYSTEMS, INC.

Version or Model: 3871

Commercial Distribution Status: Not in Commercial Distribution
Device IDs:

05415067023810 (Primary)

Catalog Number: 3871
GMDN Terms:

Multiple active implantable device programmer

SJM™ - 05415067023803

Clinician Programmer App

Company Name: ADVANCED NEUROMODULATION SYSTEMS, INC.

Version or Model: 3870

Commercial Distribution Status: Not in Commercial Distribution
Device IDs:

05415067023803 (Primary)

Catalog Number: 3870
GMDN Terms:

Multiple active implantable device programmer

Nucleus - 09321502043236

Nucleus Smart App

Company Name: COCHLEAR LIMITED

Version or Model: P1285539

Commercial Distribution Status: In Commercial Distribution
Device IDs:

09321502043236 (Primary)

Catalog Number: P1285539
GMDN Terms:

Audiometric/hearing device software

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

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

Broomwell - 00851074007293

Sirona PC App

Company Name: DATRIX LLC

Version or Model: Sirona

Commercial Distribution Status: In Commercial Distribution
Device IDs:

00851074007293 (Primary)

Catalog Number: RX22773-004
GMDN Terms:

Telemetric electrocardiographic ambulatory recorder

AMI - 00851074007255

Sirona PC App

Company Name: DATRIX LLC

Version or Model: Sirona

Commercial Distribution Status: In Commercial Distribution
Device IDs:

00851074007255 (Primary)

Catalog Number: RX22773-002
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

AMI - 00851074007231

Sirona Android App

Company Name: DATRIX LLC

Version or Model: Sirona

Commercial Distribution Status: In Commercial Distribution
Device IDs:

00851074007231 (Primary)

Catalog Number: RX22711-002
GMDN Terms:

Telemetric electrocardiographic ambulatory recorder

CardioLabs - 00851074007224

Sirona Android App

Company Name: DATRIX LLC

Version or Model: Sirona

Commercial Distribution Status: In Commercial Distribution
Device IDs:

00851074007224 (Primary)

Catalog Number: RX22711-001
GMDN Terms:

Telemetric electrocardiographic ambulatory recorder

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

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