AccessGUDID - DEVICE: Raypilot Viewcath (07350007951052)

GUDID

Device Identifier (DI) Information

Brand Name: Raypilot Viewcath
Version or Model: 1
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1005
Company Name: Micropos Medical AB (Publ)

Primary DI Number: 07350007951052
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 350533316 *Terms of Use

Device Description: Raypilot Viewcath is a Foley catheter (a sterile single-use) for treatment planning prior to radiation therapy for men with prostate cancer.

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?
65704	Radiation therapy lesion localization urethral catheter, planning	A flexible tube with a non-powered radiopaque marker (e.g., barium) at its distal end intended to be introduced into the prostatic urethra, to create an identifying mark, for the alignment and monitoring of a patient's tumour/lesion position relative to the isocentre of a radiation therapy system during treatment planning. It may allow urinary drainage or incorporate a balloon for stabilization. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IYE	Accelerator, Linear, Medical

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K203722	000

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 Atmospheric Pressure: between 70 and 106 KiloPascal
Handling Environment Humidity: between 30 and 70 Percent (%) Relative Humidity
Handling Environment Temperature: between 10 and 40 Degrees Celsius
Storage Environment Humidity: between 30 and 70 Percent (%) Relative Humidity
Storage Environment Temperature: between 10 and 40 Degrees Celsius
Storage Environment Atmospheric Pressure: between 70 and 106 KiloPascal

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 380efe5a-d300-4592-943f-04f0fe485395
Public Version Date: March 13, 2025
Public Version Number: 4
DI Record Publish Date: April 04, 2023