AccessGUDID - DEVICE: Vaginal Applicator Set with CT Cylinders (00816389022997)

GUDID

Device Identifier (DI) Information

Brand Name: Vaginal Applicator Set with CT Cylinders
Version or Model: GM11004140
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Varian Medical Systems Deutschland GmbH

Primary DI Number: 00816389022997
Issuing Agency: GS1
Commercial Distribution End Date: September 19, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 332474605 *Terms of Use

Device Description: No description.

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
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:	Yes
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?
38417	Tongue brachytherapy system applicator, remote-afterloading	A remote afterloading brachytherapy applicator specifically designed for use in radiation therapy treatments of the tongue or oral cavity. It is typically designed for temporary implantation within the tongue and/or the tissue surrounding the tongue and serves as a guide for computer-controlled placement and removal of single or multiple radioactive sources. 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 [?]
K033371	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
Moist Heat or Steam Sterilization

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: bec25292-3073-4b8f-a3be-84498f59524b
Public Version Date: December 01, 2020
Public Version Number: 4
DI Record Publish Date: September 22, 2016