Kobold® Henschke-model Tandem and Ovoid Applicator Set (E)

GUDID 00815568020007

KOBOLD, LLC

Cervical/intrauterine brachytherapy system applicator, remote-afterloading

• Primary Device ID: 00815568020007
• NIH Device Record Key: c20492a6-0bb2-4cad-a509-c39499e198af
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Kobold® Henschke-model Tandem and Ovoid Applicator Set (E)
• Version Model Number: 704-000
• Company DUNS: 014292258
• Company Name: KOBOLD, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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	00815568020007 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123912

FDA Product Code

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

Sterilization

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

[00815568020007]

Moist Heat or Steam Sterilization

[00815568020007]

Moist Heat or Steam Sterilization

[00815568020007]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-12-16
• Device Publish Date: 2016-09-23

On-Brand Devices [Kobold® Henschke-model Tandem and Ovoid Applicator Set (E)]

• 00815568020007: 704-000
• 00815568020922: Labelled with CE mark