D&K Technologies

GUDID 00869047000455

System Arm, Stabilizer, Stepper & Stand

HITACHI HEALTHCARE AMERICAS CORPORATION

Prostate brachytherapy system applicator, manual

• Primary Device ID: 00869047000455
• NIH Device Record Key: 6c6fa375-668e-4579-9f1f-f8a0ecf43ae5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: D&K Technologies
• Version Model Number: DK-ARM-KIT
• Company DUNS: 603156043
• Company Name: HITACHI HEALTHCARE AMERICAS CORPORATION
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00869047000455 [Primary]

FDA Product Code

• IWJ: System, Applicator, Radionuclide, Manual

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-02-23
• Device Publish Date: 2021-02-15

On-Brand Devices [D&K Technologies]

• 00869047000462: System Arm, Stabilizer, Stepper & Stand
• 00869047000455: System Arm, Stabilizer, Stepper & Stand