AccessGUDID - DEVICE: Raypilot System Cable (07350007956026)

GUDID

Device Identifier (DI) Information

Brand Name: Raypilot System Cable
Version or Model: 1
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 6002
Company Name: Micropos Medical AB (Publ)

Primary DI Number: 07350007956026
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 350533316 *Terms of Use

Device Description: Cable connecting the Raypilot Power box to the Raypilot Receiver

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:	No
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?
46467	Radiation therapy invasive marker lesion localization system	An assembly of noninvasive devices intended to monitor the position of a patient's tumour/lesion relative to the isocenter of a radiation therapy system, to assist with their alignment during treatment planning or a therapeutic procedure. It localizes the position of invasive markers [e.g., electromagnetic (EM) signal transmitters, radiopaque markers] (not included) which have been introduced/implanted in or near the target site prior to treatment. It typically includes an EM receiver and dedicated software.	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: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 1556b799-a090-49b8-9004-d653797fbca9
Public Version Date: March 20, 2025
Public Version Number: 1
DI Record Publish Date: March 12, 2025

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: Yes
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +46317608005
Email: info@micropos.se

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