AccessGUDID - DEVICE: Vaginal CT/MR Multi Channel Applicator (08717213024007)

GUDID

Device Identifier (DI) Information

Brand Name: Vaginal CT/MR Multi Channel Applicator
Version or Model: 110761P01-01
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Nucletron B.V.

Primary DI Number: 08717213024007
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 415269930 *Terms of Use

Device Description: Vaginal CT/MR Multi Channel Components Set, 35 mm

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
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:	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?
38409	Cervical/intrauterine brachytherapy system applicator, remote-afterloading	A remote afterloading brachytherapy applicator specifically designed for use in cervical or intrauterine radiation therapy treatments. It is designed for temporary implantation within the body and serve as a guide for computer-controlled placement and removal of single or multiple radioactive sources in the cervical or intrauterine anatomy. This GMDN code includes a wide 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 [?]
K111973	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
Outer Diameter: 35.0 Millimeter
Device Size Text, specify:

Device Record Status

Public Device Record Key: d146c8c4-10ed-4fb5-9ce0-56bd82a0ad78
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 10, 2016