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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GN Hearing - 05708296229185

APP,JABRA,ENHANCE,1.0.0,IOS

Company Name: Gn Hearing A/S

Version or Model: 22153200

Commercial Distribution Status: In Commercial Distribution
Device IDs:

05708296229185 (Primary)

Catalog Number:
GMDN Terms:

Hearing aid/implant system remote control

GN Hearing - 05708296214662

APP,JABRA,ENHANCE PRO,IOS

Company Name: Gn Hearing A/S

Version or Model: 21820200

Commercial Distribution Status: In Commercial Distribution
Device IDs:

05708296214662 (Primary)

Catalog Number:
GMDN Terms:

Hearing aid/implant system remote control

GN Hearing - 05708296214655

APP,JABRA,ENHANCE PRO,ANDR

Company Name: Gn Hearing A/S

Version or Model: 21820100

Commercial Distribution Status: In Commercial Distribution
Device IDs:

05708296214655 (Primary)

Catalog Number:
GMDN Terms:

Hearing aid/implant system remote control

GN Hearing - 05708296158478

APP,GNH TUNER,4.0,ANDR

Company Name: Gn Hearing A/S

Version or Model: 20993700

Commercial Distribution Status: In Commercial Distribution
Device IDs:

05708296158478 (Primary)

Catalog Number:
GMDN Terms:

Hearing aid/implant system remote control

GN Hearing - 05708296158461

APP,GNH TUNER,4.0,IOS

Company Name: Gn Hearing A/S

Version or Model: 20993600

Commercial Distribution Status: In Commercial Distribution
Device IDs:

05708296158461 (Primary)

Catalog Number:
GMDN Terms:

Hearing aid/implant system remote control

Beltone - 05708296158454

APP,BT HEARP,4.0,ANDR

Company Name: Gn Hearing A/S

Version or Model: 20993500

Commercial Distribution Status: In Commercial Distribution
Device IDs:

05708296158454 (Primary)

Catalog Number:
GMDN Terms:

Hearing aid/implant system remote control

Beltone - 05708296158447

APP,BT HEARP,4.0,IOS

Company Name: Gn Hearing A/S

Version or Model: 20993400

Commercial Distribution Status: In Commercial Distribution
Device IDs:

05708296158447 (Primary)

Catalog Number:
GMDN Terms:

Hearing aid/implant system remote control

GN ReSound - 05708296158430

APP,RS SMART,4.0,ANDR

Company Name: Gn Hearing A/S

Version or Model: 20993300

Commercial Distribution Status: In Commercial Distribution
Device IDs:

05708296158430 (Primary)

Catalog Number:
GMDN Terms:

Hearing aid/implant system remote control

GN ReSound - 05708296158423

APP,RS SMART,4.0,IOS

Company Name: Gn Hearing A/S

Version or Model: 20993200

Commercial Distribution Status: In Commercial Distribution
Device IDs:

05708296158423 (Primary)

Catalog Number:
GMDN Terms:

Hearing aid/implant system remote control

GN ReSound - 05708296158416

APP,KS CHOICE,4.0,ANDR

Company Name: Gn Hearing A/S

Version or Model: 20993100

Commercial Distribution Status: In Commercial Distribution
Device IDs:

05708296158416 (Primary)

Catalog Number:
GMDN Terms:

Hearing aid/implant system remote control

GN ReSound - 05708296158409

APP,KS CHOICE,4.0,IOS

Company Name: Gn Hearing A/S

Version or Model: 20993000

Commercial Distribution Status: In Commercial Distribution
Device IDs:

05708296158409 (Primary)

Catalog Number:
GMDN Terms:

Hearing aid/implant system remote control

GN ReSound - 05708296076703

APP,KS CHOICE,3.2.2,ANDR

Company Name: Gn Hearing A/S

Version or Model: 20425500

Commercial Distribution Status: In Commercial Distribution
Device IDs:

05708296076703 (Primary)

Catalog Number:
GMDN Terms:

Hearing aid/implant system remote control

GN ReSound - 05708296076697

APP,KS CHOICE,3.2.2,IOS

Company Name: Gn Hearing A/S

Version or Model: 20425400

Commercial Distribution Status: In Commercial Distribution
Device IDs:

05708296076697 (Primary)

Catalog Number:
GMDN Terms:

Hearing aid/implant system remote control

Protekt Aire Replacement Pump - 05060488570377

Protekt Adjustable APP Pump Only

Company Name: PROACTIVE MEDICAL PRODUCTS, LLC

Version or Model: 80010-PUMP

Commercial Distribution Status: In Commercial Distribution
Device IDs:

05060488570377 (Primary)

Device Sizes:

Width: 13 Inch
Length: 7.5 Inch
Height: 9 Inch

Catalog Number: 80010-PUMP
GMDN Terms:

Alternating-pressure bed mattress overlay system

Lexie Hearing - 00850022464263

iOS Hearing Aid Programming App

Company Name: HEARX GROUP (PTY) LTD

Version or Model: Lexie iOS App

Commercial Distribution Status: In Commercial Distribution
Device IDs:

00850022464263 (Primary)

Catalog Number: Lexie iOS App
GMDN Terms:

Audiometric/hearing device software

Lexie Hearing - 00850022464256

Android Hearing Aid Programming App

Company Name: HEARX GROUP (PTY) LTD

Version or Model: Lexie Android App

Commercial Distribution Status: In Commercial Distribution
Device IDs:

00850022464256 (Primary)

Catalog Number: Lexie Android App
GMDN Terms:

Audiometric/hearing device software

Halo Systems - 05690977308701

J TONG MED/LGE-No App

Company Name: OSSUR AMERICAS, INC.

Version or Model: JT-115

Commercial Distribution Status: Not in Commercial Distribution
Device IDs:

05690977308701 (Primary)

Catalog Number: JT-115
GMDN Terms:

Traction system skull tongs

N/A - 00721902865572

SFTWR 9730896 CRANIAL APP - PLUS

Company Name: MEDTRONIC NAVIGATION, INC.

Version or Model: 9730896

Commercial Distribution Status: In Commercial Distribution
Device IDs:

00721902865572 (Primary)

Catalog Number:
GMDN Terms:

Multi-purpose stereotactic surgery system

Sony - 05714880199420

Sony | Hearing Control App WA

Company Name: Ws Audiology Usa, Inc.

Version or Model: Sony | Hearing Control WA

Commercial Distribution Status: In Commercial Distribution
Device IDs:

05714880199420 (Primary)

Catalog Number: 21026345
GMDN Terms:

Audiometric/hearing device software

n.a. - 04048551054543

BARANY Noise App. w. olive

Company Name: Karl Storz GmbH & Co. KG

Version or Model: 130000

Commercial Distribution Status: In Commercial Distribution
Device IDs:

04048551054543 (Primary)

Catalog Number:
GMDN Terms:

Audiometric-evaluation noise system

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