AccessGUDID - DEVICE: Advantage Pd-103® (M936PEPS9)

GUDID

Device Identifier (DI) Information

Brand Name: Advantage Pd-103®
Version or Model: PEPS
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: ISOAID, L.L.C.

Primary DI Number: M936PEPS9
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 9
Labeler D-U-N-S® Number*: 002751241 *Terms of Use

Device Description: Advantage Pd-103 radioactive seeds with a molded form that is shielded on one side containing grooved positions for manual brachytherapy sources on the other side used for the temporary topical application of brachytherapy sources to the surface of the eye; sterile.

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?
38434	Eye brachytherapy system applicator, manual	A device in the form of a template that is shielded on one side and containing grooved positions for manual brachytherapy sources on the other used for the temporary topical application of brachytherapy sources to the surface of the eye.	Active	false
38303	Manual brachytherapy source, permanent implant	A device that is a naturally-occurring, accelerator- or reactor-produced radioactive isotope and intended to be permanently implanted into the body in order to deliver curative or palliative radiotherapy treatments. It is typically placed in the body by means of an applicator using either fluoroscopic or endoscopic guidance. Manually implanted sources intended for permanent implantation are designed to be histocompatible. It may take the form of, e.g., microspheres, spheres, stents, seeds or wires selected for producing low energy photons, beta or alpha particles.	Active	true

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: Yes

Sterilization Method [?]
Ethylene Oxide
Moist Heat or Steam Sterilization

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: 2875fd3d-9b04-491f-bcd0-3391563b02b2
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: February 04, 2016