Brachytherapy Kit

GUDID B165564203260924122

(1) 5641- 15ga, 30cm catheter w/button. 5/pk (1) 5621- 17ga, 20cm implant needles w/stylet, 5/pk (1) 5910- buttons, 5/pk, assorted colors

Liberty Medical , Inc.

Prostate brachytherapy system applicator, manual

• Primary Device ID: B165564203260924122
• NIH Device Record Key: a2e2bfbd-3604-4413-9680-429662dd07dc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Brachytherapy Kit
• Version Model Number: 5642
• Company DUNS: 967592978
• Company Name: Liberty Medical , Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

• Needle Gauge: 15 Gauge
• Needle Gauge: 15 Gauge
• Needle Gauge: 15 Gauge
• Needle Gauge: 15 Gauge
• Needle Gauge: 15 Gauge
• Needle Gauge: 15 Gauge
• Needle Gauge: 15 Gauge
• Needle Gauge: 15 Gauge
• Needle Gauge: 15 Gauge
• Needle Gauge: 15 Gauge
• Needle Gauge: 15 Gauge
• Needle Gauge: 15 Gauge
• Needle Gauge: 15 Gauge
• Needle Gauge: 15 Gauge
• Needle Gauge: 15 Gauge
• Needle Gauge: 15 Gauge
• Needle Gauge: 15 Gauge

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B165564203260924122 [Primary]

FDA Product Code

• IWJ: System, Applicator, Radionuclide, Manual

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-09-25
• Device Publish Date: 2024-09-17

On-Brand Devices [Brachytherapy Kit]

• B16556550323093024039: (1) 5653- 15ga, 30cm catheter w/button. 5/pk (1) 5654- 17ga, 20cm implant needles w/stylet, 5/pk
• B16556420326033124044: (1) 5641- 15ga, 30cm catheter w/button. 5/pk (1) 5621- 17ga, 20cm implant needles w/stylet, 5/pk
• B16556480326083124112: (1) 5641- 15ga, 30cm catheter w/button. 5/pk (1) 5621- 17ga, 20cm implant needles w/stylet, 5/pk
• B165564203260924122: (1) 5641- 15ga, 30cm catheter w/button. 5/pk (1) 5621- 17ga, 20cm implant needles w/stylet, 5/pk