AccessGUDID - DEVICE: Source guide tube with locking mechanism, third-party applicator (00816389024281)

GUDID

Device Identifier (DI) Information

Brand Name: Source guide tube with locking mechanism, third-party applicator
Version or Model: GM11007620
Commercial Distribution Status: In Commercial Distribution
Catalog Number: GM11007620
Company Name: VARIAN MEDICAL SYSTEMS, INC.

Primary DI Number: 00816389024281
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 009120817 *Terms of Use

Device Description: For GammaMedplus channel 2

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?
38407	Vaginal brachytherapy system applicator, remote-afterloading	A remote afterloading brachytherapy applicator specifically designed for use in vaginal or transvaginal radiation therapy treatments. It is designed for temporary implantation within the body and serves as a guide for computer-controlled placement and removal of single or multiple radioactive sources in the vaginal area. This GMDN code includes a variety of applicators, e.g., hollow needles or tubes and 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 [?]
K952913	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: e9eaf20f-6748-4a1f-b858-369cb6a21435
Public Version Date: February 10, 2021
Public Version Number: 1
DI Record Publish Date: February 02, 2021