AccessGUDID - DEVICE: BrachyStar™, FastFill™ (00801741075827)

GUDID

Device Identifier (DI) Information

Brand Name: BrachyStar™, FastFill™
Version or Model: 818201
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 818201
Company Name: Bard Brachytherapy, Inc.

Primary DI Number: 00801741075827
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 185524860 *Terms of Use

Device Description: BrachyStar FastFill Seed Implant Needle with Antistatic Plastic Hub, Bone Wax Tip Insert and Lubricious Coating, 18g x 20cm Length

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?
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
IWJ	System, applicator, radionuclide, manual

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes 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
Needle Gauge: 18 Gauge

Device Record Status

Public Device Record Key: bd95c7a1-961e-45ff-aeb0-075ced60f4e0
Public Version Date: August 28, 2024
Public Version Number: 3
DI Record Publish Date: September 21, 2020