AccessGUDID - DEVICE: Varian HDR Afterloader Connectors with Obturators (25420045505046)

GUDID

Device Identifier (DI) Information

Brand Name: Varian HDR Afterloader Connectors with Obturators
Version or Model: 819002
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 819002
Company Name: Hologic, Inc.

Primary DI Number: 25420045505046
Issuing Agency: GS1
Commercial Distribution End Date: September 30, 2023
Device Count: 5
Labeler D-U-N-S® Number*: 018925968 *Terms of Use

Device Description: Varian Afterloader

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?
60421	Breast brachytherapy system applicator, remote-afterloading	A sterile, remote-afterloading brachytherapy applicator specifically designed for use in radiation therapy treatments of the breast. It is typically designed for temporary implantation within the breast and serves as a guide for computer-controlled placement and removal of single or multiple radioactive sources. Included are various types of applicators such as hollow needles, tubes, or catheters, and their associated components. This is a single-use device.	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 [?]
K092405	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: c1f04a73-9bbf-4f58-92df-200910b727ad
Public Version Date: May 03, 2024
Public Version Number: 4
DI Record Publish Date: August 04, 2016