Fletcher Williamson Applicator

GUDID 08717213009684

Ovoid Tube 1 (Rigid)

Nucletron B.V.

Cervical/intrauterine brachytherapy system applicator, remote-afterloading

• Primary Device ID: 08717213009684
• NIH Device Record Key: 4ab9831e-610e-49ee-96cd-978c6ee9699a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Fletcher Williamson Applicator
• Version Model Number: 085233-00
• Company DUNS: 415269930
• Company Name: Nucletron B.V.
• 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(770)300-9725
• Email: info.america@elekta.com

Operating and Storage Conditions

• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	08717213009684 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K983341

FDA Product Code

• JAQ: System, applicator, radionuclide, remote-controlled

Sterilization

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

[08717213009684]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-09-30
• Device Publish Date: 2019-09-21

On-Brand Devices [Fletcher Williamson Applicator]

• 08717213007789: Intrauterine Tube 30°
• 08717213009684: Ovoid Tube 1 (Rigid)