CT/MR 2/3 Channel Endometrial Applicator Set, Nucletron 0916

GUDID 00817330022776

MICK RADIO NUCLEAR INSTRUMENT, INC

General-purpose brachytherapy system applicator, manual

• Primary Device ID: 00817330022776
• NIH Device Record Key: 9d2a41e1-5a52-4dac-b1e0-ec00159000cf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CT/MR 2/3 Channel Endometrial Applicator Set, Nucletron
• Version Model Number: 0916
• Catalog Number: 0916
• Company DUNS: 073260622
• Company Name: MICK RADIO NUCLEAR INSTRUMENT, INC
• Device Count: 1
• DM Exempt: false
• 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: 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	00817330022776 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K871216

FDA Product Code

• IWJ: System, Applicator, Radionuclide, Manual

Sterilization

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

[00817330022776]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-08-06
• Device Publish Date: 2017-01-24

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