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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Medistim QuickFIT TTFM probe - 07070554100085

No Description

Company Name: Medistim ASA

Version or Model: PQ100042

Commercial Distribution Status: Not in Commercial Distribution
Device IDs:

07070554100085 (Primary)

Catalog Number: PQ100042
GMDN Terms:

Invasive vascular ultrasound system probe

Medistim QuickFIT TTFM probe - 07070554100078

No Description

Company Name: Medistim ASA

Version or Model: PQ100032

Commercial Distribution Status: Not in Commercial Distribution
Device IDs:

07070554100078 (Primary)

Catalog Number: PQ100032
GMDN Terms:

Invasive vascular ultrasound system probe

Medistim QuickFIT TTFM probe - 07070554100061

No Description

Company Name: Medistim ASA

Version or Model: PQ100022

Commercial Distribution Status: Not in Commercial Distribution
Device IDs:

07070554100061 (Primary)

Catalog Number: PQ100022
GMDN Terms:

Invasive vascular ultrasound system probe

Thompson - 00841536116182

Reverse Lip ASA Tapered 25 x 102mm

Company Name: THOMPSON SURGICAL INSTRUMENTS, INC.

Version or Model: 46194TE

Commercial Distribution Status: In Commercial Distribution
Device IDs:

00841536116182 (Primary)

Catalog Number:
GMDN Terms:

Surgical retraction system, reusable

MeDiCa - 00813545027131

ASA (anti-skin) Monkey Esophagus 96 Test Kit

Company Name: SCIMEDX CORPORATION

Version or Model: 6001-96-ES

Commercial Distribution Status: In Commercial Distribution
Device IDs:

00813545027131 (Primary)

Catalog Number: 6001-96-ES
GMDN Terms:

Skin antibody IVD, kit, fluorescent immunoassay

MeDiCa - 00813545027124

ASA (anti-skin) Monkey Esophagus 48 Test Kit

Company Name: SCIMEDX CORPORATION

Version or Model: 6001-48-ES

Commercial Distribution Status: In Commercial Distribution
Device IDs:

00813545027124 (Primary)

Catalog Number: 6001-48-ES
GMDN Terms:

Skin antibody IVD, kit, fluorescent immunoassay

StealthStation Cranial Software - 00643169865341

SW APP 9735762 STEALTH S8 APP

Company Name: MEDTRONIC NAVIGATION, INC.

Version or Model: 9735762

Commercial Distribution Status: In Commercial Distribution
Device IDs:

00643169865341 (Primary)

Catalog Number:
GMDN Terms:

Multi-purpose stereotactic surgery system

Rexton - 05714880113204

APP REXTON

Company Name: Ws Audiology Usa, Inc.

Version or Model: Rexton App

Commercial Distribution Status: In Commercial Distribution
Device IDs:

05714880113204 (Primary)

Catalog Number: 10996567
GMDN Terms:

Hearing aid/implant system remote control

AudioService - 05714880113198

APP AUDIOSERVICE

Company Name: Ws Audiology Usa, Inc.

Version or Model: AudioService App

Commercial Distribution Status: In Commercial Distribution
Device IDs:

05714880113198 (Primary)

Catalog Number: 10996566
GMDN Terms:

Hearing aid/implant system remote control

myRemote - 05714880113181

APP MYREMOTE

Company Name: Ws Audiology Usa, Inc.

Version or Model: myRemote App

Commercial Distribution Status: In Commercial Distribution
Device IDs:

05714880113181 (Primary)

Catalog Number: 10996565
GMDN Terms:

Hearing aid/implant system remote control

Vibe - 05714880113174

APP VIBE

Company Name: Ws Audiology Usa, Inc.

Version or Model: Vibe App

Commercial Distribution Status: In Commercial Distribution
Device IDs:

05714880113174 (Primary)

Catalog Number: 10996564
GMDN Terms:

Hearing aid/implant system remote control

Signia - 05714880113167

APP SIGNIA

Company Name: Ws Audiology Usa, Inc.

Version or Model: Signia App

Commercial Distribution Status: In Commercial Distribution
Device IDs:

05714880113167 (Primary)

Catalog Number: 10996563
GMDN Terms:

Hearing aid/implant system remote control

TruHearing - 05714880113150

APP TRUHEARING

Company Name: Ws Audiology Usa, Inc.

Version or Model: TruHearing App

Commercial Distribution Status: In Commercial Distribution
Device IDs:

05714880113150 (Primary)

Catalog Number: 10996369
GMDN Terms:

Hearing aid/implant system remote control

Hearing Help Express - 00858177007335

Android App

Company Name: INTRICON CORPORATION

Version or Model: HHE Hearing

Commercial Distribution Status: In Commercial Distribution
Device IDs:

00858177007335 (Primary)

Catalog Number: 23354
GMDN Terms:

Audiometric/hearing device software

hiHealth Innovations - 00858177007144

Android App

Company Name: INTRICON CORPORATION

Version or Model: hiHearing

Commercial Distribution Status: In Commercial Distribution
Device IDs:

00858177007144 (Primary)

Catalog Number: 22958
GMDN Terms:

Audiometric/hearing device software

Hearing Help Express - 00858177007113

iOS App

Company Name: INTRICON CORPORATION

Version or Model: HHE Hearing

Commercial Distribution Status: In Commercial Distribution
Device IDs:

00858177007113 (Primary)

Catalog Number: 23150
GMDN Terms:

Audiometric/hearing device software

Sonova - 07613389310979

myPhonak app

Company Name: Sonova AG

Version or Model: 088-0011

Commercial Distribution Status: In Commercial Distribution
Device IDs:

07613389310979 (Primary)

Catalog Number: 088-0011
GMDN Terms:

Audiometric/hearing device software

Phonak - 07613389082623

myPhonak (App)

Company Name: Sonova AG

Version or Model: 088-0008-03

Commercial Distribution Status: In Commercial Distribution
Device IDs:

07613389082623 (Primary)

Catalog Number: 088-0008-03
GMDN Terms:

Audiometric/hearing device software

PRC - 00816486021060

Quasselkiste App

Company Name: PRENTKE ROMICH COMPANY

Version or Model: Quasselkiste App

Commercial Distribution Status: In Commercial Distribution
Device IDs:

00816486021060 (Primary)

Catalog Number: 19285-2
GMDN Terms:

Voice synthesizer/digitizer

audifon - EADF03410600217207189

audifon APP

Company Name: audifon GmbH & Co. KG

Version or Model: audifon APP 1.4.3

Commercial Distribution Status: In Commercial Distribution
Device IDs:

EADF03410600217207189 (Primary)

Catalog Number: 03410600217207189
GMDN Terms:

Hearing aid wireless-fitting computer-aided set

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