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

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

Class II (2408)

Implantable

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DreamMapper - 00606959057692

DreamMapper App iOS

Company Name: Respironics, Inc.

Version or Model: DreamMapper iOS, North American Instance - 2

Commercial Distribution Status: In Commercial Distribution
Device IDs:

00606959057692 (Primary)

Catalog Number: 1101478
GMDN Terms:

Self-care monitoring/reporting software

DreamMapper App iOS - 00606959048560

DreamMapper App iOS

Company Name: Respironics, Inc.

Version or Model: 2.9

Commercial Distribution Status: In Commercial Distribution
Device IDs:

00606959048560 (Primary)

Catalog Number: 1101478
GMDN Terms:

Self-care monitoring/reporting software

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

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

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