Kobold® Miami Cylinder Applicator Set (V)

GUDID 00815568020236

KOBOLD, LLC

Cervical/intrauterine brachytherapy system applicator, remote-afterloading Cervical/intrauterine brachytherapy system applicator, remote-afterloading Cervical/intrauterine brachytherapy system applicator, remote-afterloading

• Primary Device ID: 00815568020236
• NIH Device Record Key: d37bcb16-e5f5-42ca-8a1f-cead4e539a95
• Commercial Distribution Discontinuation: 2019-07-26
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Kobold® Miami Cylinder Applicator Set (V)
• Version Model Number: 706-000
• 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	00815568020236 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123941

FDA Product Code

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

Sterilization

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

[00815568020236]

Moist Heat or Steam Sterilization

[00815568020236]

Moist Heat or Steam Sterilization

[00815568020236]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-08-19
• Device Publish Date: 2016-09-23

Devices Manufactured by KOBOLD, LLC

• 00815568020892 - Kobold® Prostate HDR Stepper Template - 6 Fr: 2019-12-17 Labelled with CE
• 00815568020922 - Kobold® Henschke-model Tandem and Ovoid Applicator Set (E): 2019-12-16 Labelled with CE mark
• 00815568020977 - Kobold® Fletcher-model Tandem and Barrel Ovoid Applicator Set (E): 2019-12-16 Labelled with CE mark
• 00815568020984 - Kobold® Fletcher-model Tandem and Cylinder Ovoid Applicator Set (E): 2019-12-16 Labelled with CE mark
• 00815568020991 - Kobold® Vaginal Cylinder Applicator Set (E): 2019-12-16 Labelled with CE mark
• 00815568020007 - Kobold® Henschke-model Tandem and Ovoid Applicator Set (E): 2019-12-16
• 00815568020014 - Kobold® Fletcher-model Tandem and Barrel Ovoid Applicator Set (E): 2019-12-16
• 00815568020021 - Kobold® Fletcher-model Tandem and Cylinder Ovoid Applicator Set (E): 2019-12-16