AccessGUDID - DEVICE: Intraluminal Applicator Set (00810563022834)

GUDID

Device Identifier (DI) Information

Brand Name: Intraluminal Applicator Set
Version or Model: GM11000620
Commercial Distribution Status: In Commercial Distribution
Catalog Number: GM11000620
Company Name: Varian Medical Systems Deutschland GmbH

Primary DI Number: 00810563022834
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 332474605 *Terms of Use

Device Description: Intraluminal Applicator Set

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):	No
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?
38411	Bronchial brachytherapy system applicator, remote-afterloading	A remote afterloading brachytherapy applicator specifically designed for use in bronchial radiation therapy treatments. It is designed for temporary placement within the body and serve as a guide for computer-controlled placement and removal of single or multiple radioactive sources in the bronchial area. This GMDN code includes a variety of applicators, e.g., hollow needles, tubes or catheters, and their associated components.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JAQ	System, applicator, radionuclide, remote-controlled

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K151022	000
K242961	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: 37082c36-cbed-45d9-9a55-30ea9c67fec7
Public Version Date: December 09, 2024
Public Version Number: 2
DI Record Publish Date: September 30, 2024