CT/MR FSD Ovoid Pair, 3.0cm diam 0612-12

GUDID 00817330021342

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: 00817330021342
• NIH Device Record Key: 6417716d-982e-4faf-89ec-61e7a17f1338
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CT/MR FSD Ovoid Pair, 3.0cm diam
• Version Model Number: 0612-12
• Catalog Number: 0612-12
• 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: 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817330021342 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K063381

FDA Product Code

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

Sterilization

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

[00817330021342]

Moist Heat or Steam Sterilization

[00817330021342]

Moist Heat or Steam Sterilization

[00817330021342]

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 FSD Ovoid Pair, 3.0cm diam]

• 00817330021397: 0612-10
• 00817330021342: 0612-12