BEUDAMED

FDA UDI In Commercial Distribution 🇺🇸 United States

aScope™ 4 Cysto

DI: 05707480140558 · Model: 600001000 · Ambu A/S

View on AccessGUDID

Product Codes

1

GMDN Terms

1

Identifiers

3

Pkg Device Count

1

Let the assistant research this device

The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.

Free to try · every answer cites its records

Ask the Research Assistant See examples

Basic Information

Brand Name: aScope™ 4 Cysto
Primary DI: 05707480140558
Version / Model: 600001000
Catalog Number: 600001000
Company Name: Ambu A/S
Labeler DUNS: 305682023
Distribution Status: In Commercial Distribution
Device Count in Pkg: 1
Record Status: Published
Publish Date: 2021-02-04
Public Version: 3
Public Version Date: 2026-01-30
Public Version Status: Update
Public Device Record Key: e256eca0-995c-43ee-b0ef-fba6a5c7379e

Device Description

aScope 4 Cysto - Reverse Deflection

Device Characteristics

Single Use: Yes
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: No
Has Lot/Batch Number: Yes
Has Manufacturing Date: No
Has Expiration Date: Yes
Has Donation ID: No

Sterilization

Is Sterile: No
Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FAJ	Cystoscope and accessories, flexible/rigid	Gastroenterology, Urology	876.1500	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61728	Flexible video cystoscope, single-use	A sterile endoscope with a flexible inserted portion intended for the visual examination and treatment of the bladder and the urinary tract by introduction through the urethra. Anatomical images are transmitted from a distal camera and displayed on a monitor. It is typically used to examine/diagnose incontinence, urinary retention, recurrent urinary tract infections, and/or to remove tissue specimens/stones/small tumours from the bladder; it may have specialized tools for functions such as ureteral stent removal. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	05707480140565	GS1		5	In Commercial Distribution
Primary	05707480140558	GS1
Package	05707480140572	GS1		4	In Commercial Distribution

Customer Contacts

Phone: +1(410)768-6464
Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Length	390	Millimeter
Outer Diameter	6	Millimeter
Lumen/Inner Diameter	2.2	Millimeter

Storage Conditions

Type: Storage Environment Humidity
Temperature Range: 10 – 85 Percent (%) Relative Humidity
Type: Handling Environment Atmospheric Pressure
Temperature Range: 80 – 106 KiloPascal
Type: Handling Environment Humidity
Temperature Range: 30 – 85 Percent (%) Relative Humidity
Type: Storage Environment Temperature
Temperature Range: 10 – 25 Degrees Celsius
Type: Storage Environment Atmospheric Pressure
Temperature Range: 50 – 106 KiloPascal
Type: Handling Environment Temperature
Temperature Range: 10 – 40 Degrees Celsius