AccessGUDID - DEVICE: PL-7 Cs-131 Brachytherapy Seeds in Preloaded Strands with MRI Markers (M748PL70)

GUDID

Device Identifier (DI) Information

Brand Name: PL-7 Cs-131 Brachytherapy Seeds in Preloaded Strands with MRI Markers
Version or Model: PL-7
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: ISORAY MEDICAL, INC.

Primary DI Number: M748PL70
Issuing Agency: HIBCC
Commercial Distribution End Date: April 19, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 113577485 *Terms of Use

Device Description: The Isoray Cesium-131 Implant Devices combined with MRI Markers will be used to facilitate the anatomical location of seeds after they have been implanted in the prostate of a patient with confirmed prostatic malignancy. The PL-7 device is preloaded strands with Markers.

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:	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?
38435	General-purpose brachytherapy system applicator, manual	A general-purpose brachytherapy applicator designed to facilitate delivery of radiation therapy treatments that are not specific to a particular anatomical region. It is an individual or modular device designed to facilitate manual placement, e.g., puncture, topical placement, endoscopically guided placement or diagnostic imaging system guided placement, and removal of single or multiple radioactive sources at a treatment site. The device may be a fixed design or designed to facilitate the creation of variable physical configurations or individual patient source placement configurations and includes general-purpose applicators such as hollow needles, tubes or catheters, ovoids or tandems.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KXK	Source, Brachytherapy, Radionuclide

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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: 47c588b7-52ed-430e-ae17-5165bbda738b
Public Version Date: April 23, 2024
Public Version Number: 2
DI Record Publish Date: April 23, 2021