GUDID 08717213011571

X-Ray Catheter 150 cm (5)

Nucletron B.V.

Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable

• Primary Device ID: 08717213011571
• NIH Device Record Key: 9701f0ec-645a-45ce-9ab5-edf9ddf42a44
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 089515P01-00
• Company DUNS: 415269930
• Company Name: Nucletron B.V.
• Device Count: 1
• 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: 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

Customer Support Contacts

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

Device Dimensions

• Length: 151 Centimeter
• Length: 151 Centimeter
• Length: 151 Centimeter
• Length: 151 Centimeter
• Length: 151 Centimeter
• Length: 151 Centimeter
• Length: 151 Centimeter
• Length: 151 Centimeter
• Length: 151 Centimeter
• Length: 151 Centimeter
• Length: 151 Centimeter
• Length: 151 Centimeter
• Length: 151 Centimeter
• Length: 151 Centimeter
• Length: 151 Centimeter
• Length: 151 Centimeter
• Length: 151 Centimeter
• Length: 151 Centimeter
• Length: 151 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	08717213011571 [Direct Marking]
GS1	08717213043015 [Primary]

FDA Product Code

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

Sterilization

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

[08717213011571]

Moist Heat or Steam Sterilization

[08717213011571]

Moist Heat or Steam Sterilization

[08717213011571]

Moist Heat or Steam Sterilization

[08717213011571]

Moist Heat or Steam Sterilization

[08717213011571]

Moist Heat or Steam Sterilization

[08717213011571]

Moist Heat or Steam Sterilization

[08717213011571]

Moist Heat or Steam Sterilization

[08717213011571]

Moist Heat or Steam Sterilization

[08717213011571]

Moist Heat or Steam Sterilization

[08717213011571]

Moist Heat or Steam Sterilization

[08717213011571]

Moist Heat or Steam Sterilization

[08717213011571]

Moist Heat or Steam Sterilization

[08717213011571]

Moist Heat or Steam Sterilization

[08717213011571]

Moist Heat or Steam Sterilization

[08717213011571]

Moist Heat or Steam Sterilization

[08717213011571]

Moist Heat or Steam Sterilization

[08717213011571]

Moist Heat or Steam Sterilization

[08717213011571]

Moist Heat or Steam Sterilization

[08717213011571]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2022-06-10
• Device Publish Date: 2016-09-10

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)