CT/MR Contour Prostate Template, HDR Sm B&K 15.5G 1204-05-15.5G

GUDID 00817330023339

MICK RADIO NUCLEAR INSTRUMENT, INC

General-purpose brachytherapy system applicator, manual General-purpose brachytherapy system applicator, manual General-purpose brachytherapy system applicator, manual

• Primary Device ID: 00817330023339
• NIH Device Record Key: 2cabb0fa-0964-4680-9f4e-87ffe42c9a59
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CT/MR Contour Prostate Template, HDR Sm B&K 15.5G
• Version Model Number: 1204-05-15.5G
• Catalog Number: 1204-05-15.5G
• Company DUNS: 073260622
• Company Name: MICK RADIO NUCLEAR INSTRUMENT, INC
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817330023339 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K993400

FDA Product Code

• JAQ: System, Applicator, Radionuclide, Remote-Controlled

Sterilization

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

[00817330023339]

Moist Heat or Steam Sterilization

[00817330023339]

Moist Heat or Steam Sterilization

[00817330023339]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-10-14

On-Brand Devices [CT/MR Contour Prostate Template, HDR Sm B&K 15.5G]

• 00817330023339: 1204-05-15.5G
• 00817330023223: 1204-02-15.5G
• 00817330023155: 1204-05-15.5G