Henschke Ovoids With Tungsten Segments & Caps Set 6402-05

GUDID 00817330024497

MICK RADIO NUCLEAR INSTRUMENT, INC

Cervical/intrauterine brachytherapy system applicator, manual Cervical/intrauterine brachytherapy system applicator, manual Cervical/intrauterine brachytherapy system applicator, manual

• Primary Device ID: 00817330024497
• NIH Device Record Key: 3d1e3a80-6352-41e9-aa4f-19c130611bd1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Henschke Ovoids With Tungsten Segments & Caps Set
• Version Model Number: 6402-05
• Catalog Number: 6402-05
• 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: 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	00817330024497 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K040704

FDA Product Code

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

Sterilization

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

[00817330024497]

Moist Heat or Steam Sterilization

[00817330024497]

Moist Heat or Steam Sterilization

[00817330024497]

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 [Henschke Ovoids With Tungsten Segments & Caps Set]

• 00817330024497: 6402-05
• 00817330020000: 6402-05