Valencia Skin Applicator

GUDID 08717213032071

Valencia Ft Skin Applicator, Ø 20mm

Nucletron B.V.

General-purpose brachytherapy system applicator, remote-afterloading

• Primary Device ID: 08717213032071
• NIH Device Record Key: dd8739cf-7327-4cfd-a9c2-9b26f804010d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Valencia Skin Applicator
• Version Model Number: 110821-00
• 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

Device Dimensions

• Outer Diameter: 20 Millimeter

Operating and Storage Conditions

• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	08717213032071 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K073107

FDA Product Code

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

Sterilization

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

[08717213032071]

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 [Valencia Skin Applicator]

• 08717213031852: Advanced Skin Applicator Set
• 08717213032095: Valencia Ft Skin Applicator, 30mm
• 08717213032071: Valencia Ft Skin Applicator, Ø 20mm
• 08717213032057: Valencia Skin Applicator, 30mm
• 08717213032033: Valencia Skin Applicator, Ø 20mm