BEUDAMED

FDA UDI In Commercial Distribution 🇺🇸 United States

FibroScan

DI: 03662264001062 · Model: FibroScan 530 Compact · ECHOSENS

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Product Codes

1

GMDN Terms

1

Identifiers

1

Pkg Device Count

1

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Basic Information

Brand Name: FibroScan
Primary DI: 03662264001062
Version / Model: FibroScan 530 Compact
Company Name: ECHOSENS
Labeler DUNS: 571069108
Distribution Status: In Commercial Distribution
Device Count in Pkg: 1
Record Status: Published
Publish Date: 2016-09-23
Public Version: 4
Public Version Date: 2020-03-11
Public Version Status: Update
Public Device Record Key: e2535941-e39e-4f30-ad9e-49f6cbfd8eea

Device Characteristics

Single Use: No
Prescription Use (Rx): Yes
Over the Counter (OTC): No
Kit: No
Combination Product: No
HCT/P: No
Contains NRL: No
Not Made with NRL: No
MRI Safety: Labeling does not contain MRI Safety Information
Direct Marking Exempt: No
PM Exempt: No
Has Serial Number: Yes
Has Lot/Batch Number: No
Has Manufacturing Date: Yes
Has Expiration Date: No
Has Donation ID: No

Sterilization

Is Sterile: No
Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	892.1560	2

GMDN Terms

Code	Name	Definition	Implantable	Status
58710	Hepatic ultrasound elastography system	An assembly of mains electricity (AC-powered) devices, which may include rechargeable batteries, designed to measure liver stiffness/ultrasonic attenuation of tissues based on transient elastography for the evaluation/diagnosis of hepatic disease (e.g., liver fibrosis/steatosis); it may additionally be intended to measure spleen stiffness as an adjunct evaluation. It is typically used during diagnosis of chronic liver conditions such as viral hepatits, alcoholic hepatitis, and biliary disease, or for post-transplant evaluation. It consists of both a generator with dedicated software and a noninvasive applicator(s).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	03662264001062	GS1

Customer Contacts

Phone: +33149818929
Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K160524	000

Storage Conditions

Type: Storage Environment Temperature
Temperature Range: -20 – 50 Degrees Celsius
Type: Storage Environment Humidity
Temperature Range: 10 – 85 Percent (%) Relative Humidity
Type: Storage Environment Atmospheric Pressure
Temperature Range: 54 – 106 KiloPascal
Type: Handling Environment Temperature
Temperature Range: 10 – 40 Degrees Celsius
Type: Handling Environment Humidity
Temperature Range: 30 – 75 Percent (%) Relative Humidity
Type: Handling Environment Atmospheric Pressure
Temperature Range: 70 – 106 KiloPascal