AccessGUDID - DEVICE: Secure Strand with Advantage I-125 in Strand Delivery System (M936ISDS9)

GUDID

Device Identifier (DI) Information

Brand Name: Secure Strand with Advantage I-125 in Strand Delivery System
Version or Model: ISDS
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: ISOAID, L.L.C.

Primary DI Number: M936ISDS9
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 9
Labeler D-U-N-S® Number*: 002751241 *Terms of Use

Device Description: Secure Strand with Advantage I-125 in Strand Delivery System

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?
38426	Prostate brachytherapy system applicator, manual	A manual brachytherapy applicator specifically designed to be used in radiation therapy treatments of the prostate. It is an individual or modular device designed to facilitate manual placement, e.g., puncture, endoscopically guided or diagnostic imaging system guided placement, and/or removal of single or multiple radioactive sources at a treatment site within the prostate. The device may be a fixed design or designed to accommodate individual patient source placement configurations and includes prostate applicators such as hollow needles, tubes or catheters, used in manual brachytherapy applications.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KXK	Source, Brachytherapy, Radionuclide

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K113210	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Ethylene Oxide

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: 3abd0baa-8a71-450d-956d-25ae0b9ceabc
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: January 13, 2017