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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Perifit Care - 03770014642165

Kegel Exerciser with App

Company Name: X6 INNOVATIONS

Version or Model: Green Perifit Care

Commercial Distribution Status: In Commercial Distribution
Device IDs:

03770014642165 (Primary)

Catalog Number:
GMDN Terms:

Pelvic floor muscle exerciser

Perifit Care - 03770014642134

Kegel Exerciser with App

Company Name: X6 INNOVATIONS

Version or Model: Pink Perifit Care

Commercial Distribution Status: In Commercial Distribution
Device IDs:

03770014642134 (Primary)

Catalog Number:
GMDN Terms:

Pelvic floor muscle exerciser

CIONIC - G345620000040

CIONIC Android Gateway App

Company Name: Cionic, Inc.

Version or Model: 10

Commercial Distribution Status: In Commercial Distribution
Device IDs:

G345620000040 (Primary)

Catalog Number: 62000004
GMDN Terms:

Gait-enhancement electrical stimulation system, external

CIONIC - G345620000030

CIONIC iOS Gateway App

Company Name: Cionic, Inc.

Version or Model: 10

Commercial Distribution Status: In Commercial Distribution
Device IDs:

G345620000030 (Primary)

Catalog Number: 62000003
GMDN Terms:

Gait-enhancement electrical stimulation system, external

Cochlear - 09321502046145

Osia Smart App (Android)

Company Name: COCHLEAR LIMITED

Version or Model: P1340354

Commercial Distribution Status: In Commercial Distribution
Device IDs:

09321502046145 (Primary)

Catalog Number: P1340354
GMDN Terms:

Audiometric/hearing device software

Cochlear - 09321502046138

Osia Smart App (iOS)

Company Name: COCHLEAR LIMITED

Version or Model: P1340352

Commercial Distribution Status: In Commercial Distribution
Device IDs:

09321502046138 (Primary)

Catalog Number: P1340352
GMDN Terms:

Audiometric/hearing device software

Nucleus - 09321502036788

Nucleus Smart App, (iOS)

Company Name: COCHLEAR LIMITED

Version or Model: P832154

Commercial Distribution Status: In Commercial Distribution
Device IDs:

09321502036788 (Primary)

Catalog Number: P832154
GMDN Terms:

Audiometric/hearing device software

Baha - 09321502034180

Baha 5 Smart App

Company Name: Cochlear Bone Anchored Solutions AB

Version or Model: P736025

Commercial Distribution Status: Not in Commercial Distribution
Device IDs:

09321502034180 (Primary)

Catalog Number: P736025
GMDN Terms:

Hearing aid/implant system remote control

Baha - 09321502034159

Baha 5 Smart App

Company Name: Cochlear Bone Anchored Solutions AB

Version or Model: 95448

Commercial Distribution Status: Not in Commercial Distribution
Device IDs:

09321502034159 (Primary)

Catalog Number: 95448
GMDN Terms:

Hearing aid/implant system remote control

DreamMapper - 00606959057715

DreamMapper App iOS (APAC)

Company Name: Respironics, Inc.

Version or Model: DreamMapper App iOS, Asia-Pacific Instance - 2

Commercial Distribution Status: In Commercial Distribution
Device IDs:

00606959057715 (Primary)

Catalog Number: 1127959
GMDN Terms:

Self-care monitoring/reporting software

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