AccessGUDID - DEVICE: selectSeed™ I-125 (98717213037833)

GUDID

Device Identifier (DI) Information

Brand Name: selectSeed™ I-125
Version or Model: 130002-01
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 130002
Company Name: Nucletron B.V.

Primary DI Number: 98717213037833
Issuing Agency: GS1
Commercial Distribution End Date: July 17, 2019
Device Count: 100
Labeler D-U-N-S® Number*: 415269930 *Terms of Use

Device Description: Sterile IODINE—125 source for interstitial Brachytherapy for use with seedSelectron®. Quantity in package is customer order specific in range 10 – 100 seeds.

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?
38302	Remote-afterloading brachytherapy source	A device that is a naturally-occurring, accelerator or reactor produced-radioactive isotope used as a source of radiation in high or low dose rate remote afterloading brachytherapy systems designed to deliver curative or palliative radiotherapy treatments. Sources used in remote afterloading radiotherapy systems may come in a variety of strengths and physical forms, e.g., single encapsulated source (sealed source), ribbons, plated, foil or embedded sources or contained radioactive liquids or gels. It is typically housed in a shielded safe within the remote afterloading system and delivered through guide tubes or catheters to the treatment site by various remote-controlled mechanisms.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KXK	Source, Brachytherapy, Radionuclide

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K002429	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
Storage Environment Temperature: between -40 and 158 Degrees Fahrenheit
Storage Environment Temperature: between -40 and 70 Degrees Celsius
Special Storage Condition, Specify: Storage of selectSeeds™ I-125 has to be in a place with adequate radiation protection that is safe from unauthorized access, in accordance with the regulations of radionuclide laboratories.

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: fa0885c5-5aaa-4fe3-bf22-fc109bddc59e
Public Version Date: July 17, 2019
Public Version Number: 5
DI Record Publish Date: October 22, 2015