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GUDID 08717213018679

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Nucletron B.V.

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• Primary Device ID: 08717213018679
• NIH Device Record Key: c2ad8d23-4799-4686-8d5a-8e701542b326
• Commercial Distribution Discontinuation: 2019-07-17
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: selectSpacer
• Version Model Number: 130010P01-01
• Company DUNS: 415269930
• Company Name: Nucletron B.V.
• Device Count: 100
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	08717213018679 [Package]; Contains: 08717213039537; Package: [1 Units]; Discontinued: 2019-07-17; Not in Commercial Distribution
GS1	08717213038950 [Unit of Use]
GS1	08717213039537 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K010032

FDA Product Code

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

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-07-17
• Device Publish Date: 2017-05-25

Devices Manufactured by Nucletron B.V.

• 08717213054363 - Luneray: 2022-11-23 Catheter 6F 50cm, needle 37mm R30mm
• 08717213054370 - Luneray: 2022-11-23 Catheter 6F 50cm, needle 47mm R45mm
• 08717213054387 - Luneray: 2022-11-23 Catheter 6F 50cm, needle 57mm R60mm
• 08717213054394 - Luneray: 2022-11-15 Catheter 6F 50cm, needle 67mm R75mm
• 08717213057760 - Esteya: 2022-08-24 Esteya
• 08717213056947 - NA: 2022-07-08 INSERTION TOOL
• 08717213008991 - X-ray Catheters: 2022-06-10 X-Ray Catheter Set Standard USA GYN SS
• 08717213009387 - X-ray Catheters: 2022-06-10 GYN X-Ray Catheter Set (channel 1-3)