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)
UNIV (1)

Device Class

Implantable

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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

Nalu Medical, Inc. - 00812537030463

SCS Programming App

Company Name: NALU MEDICAL, INC.

Version or Model: 53001

Commercial Distribution Status: In Commercial Distribution
Device IDs:

00812537030463 (Primary)

Catalog Number: 53001
GMDN Terms:

Implantable electrical stimulation device management software

My Dose Coach - 04030685900018

Insulin Titration App

Company Name: Sanofi-Aventis Deutschland GmbH

Version or Model: 2.x.x

Commercial Distribution Status: Not in Commercial Distribution
Device IDs:

04030685900001 (Previous)
04030685900018 (Primary)

Device Sizes:

No size - Software as a Medical Device

Catalog Number: N/A
GMDN Terms:

Clinical management support software

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

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