AccessGUDID - DEVICE: Model 200 TheraSeed® Palladium-103 Device in Isosleeve™ Delivery System (00801741078514)

GUDID

Device Identifier (DI) Information

Brand Name: Model 200 TheraSeed® Palladium-103 Device in Isosleeve™ Delivery System
Version or Model: IS200
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: IS200
Company Name: Bard Brachytherapy, Inc.

Primary DI Number: 00801741078514
Issuing Agency: GS1
Commercial Distribution End Date: June 15, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 185524860 *Terms of Use

Device Description: Model 200 TheraSeed® Palladium-103 Seeds IN ISOSLEEVE, STRL

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:	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?
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
33069	Brachytherapy injection needle	A sharp bevel-edged, hollow tubular metal instrument that is used to inject radionuclide into a body cavity or tissue as a source of nuclear radiation for cancer therapy (brachytherapy). The device may be pre-sterilized and preloaded, and may have a tip enhanced for ultrasound-guided implantation. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KXK	Source, brachytherapy, radionuclide

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K060636	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 2976e508-c14b-470c-a1b8-134899913913
Public Version Date: May 03, 2024
Public Version Number: 6
DI Record Publish Date: October 05, 2015