AccessGUDID - DEVICE: aScope™ 4 Cysto (05707480157921)

GUDID

Device Identifier (DI) Information

Brand Name: aScope™ 4 Cysto
Version or Model: 600177000
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 600177000
Company Name: Ambu A/S

Primary DI Number: 05707480157921
Issuing Agency: GS1
Commercial Distribution End Date: September 11, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 305682023 *Terms of Use

Device Description: aScope 4 Cysto - Reverse Deflection Bosma

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FAJ	Cystoscope and accessories, flexible/rigid

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Handling Environment Temperature: between 10 and 40 Degrees Celsius
Handling Environment Humidity: between 30 and 85 Percent (%) Relative Humidity
Storage Environment Temperature: between 10 and 40 Degrees Celsius
Storage Environment Humidity: between 10 and 85 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: fe558ae8-ca0e-44fd-a87d-e979ef9f1aa9
Public Version Date: October 28, 2024
Public Version Number: 2
DI Record Publish Date: September 21, 2022