X-ray Catheters

GUDID 08717213011182

X-Ray Catheter 30 cm (6)

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: 08717213011182
• NIH Device Record Key: 5fec9fe5-215e-41c1-b3de-3ab00fcefad3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: X-ray Catheters
• Version Model Number: 089426P01-00
• 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: 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: 30 Centimeter
• Device Size Text, specify: 0
• Length: 30 Centimeter
• Device Size Text, specify: 0
• Length: 30 Centimeter
• Device Size Text, specify: 0
• Length: 30 Centimeter
• Device Size Text, specify: 0
• Length: 30 Centimeter
• Device Size Text, specify: 0
• Length: 30 Centimeter
• Device Size Text, specify: 0
• Length: 30 Centimeter
• Device Size Text, specify: 0
• Length: 30 Centimeter
• Device Size Text, specify: 0
• Length: 30 Centimeter
• Device Size Text, specify: 0
• Length: 30 Centimeter
• Device Size Text, specify: 0
• Length: 30 Centimeter
• Device Size Text, specify: 0
• Length: 30 Centimeter
• Device Size Text, specify: 0
• Length: 30 Centimeter
• Device Size Text, specify: 0
• Length: 30 Centimeter
• Device Size Text, specify: 0
• Length: 30 Centimeter
• Device Size Text, specify: 0
• Length: 30 Centimeter
• Device Size Text, specify: 0
• Length: 30 Centimeter
• Device Size Text, specify: 0
• Length: 30 Centimeter
• Device Size Text, specify: 0
• Length: 30 Centimeter
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	08717213011182 [Direct Marking]
GS1	08717213042636 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K070574

FDA Product Code

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

Sterilization

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

[08717213011182]

Moist Heat or Steam Sterilization

[08717213011182]

Moist Heat or Steam Sterilization

[08717213011182]

Moist Heat or Steam Sterilization

[08717213011182]

Moist Heat or Steam Sterilization

[08717213011182]

Moist Heat or Steam Sterilization

[08717213011182]

Moist Heat or Steam Sterilization

[08717213011182]

Moist Heat or Steam Sterilization

[08717213011182]

Moist Heat or Steam Sterilization

[08717213011182]

Moist Heat or Steam Sterilization

[08717213011182]

Moist Heat or Steam Sterilization

[08717213011182]

Moist Heat or Steam Sterilization

[08717213011182]

Moist Heat or Steam Sterilization

[08717213011182]

Moist Heat or Steam Sterilization

[08717213011182]

Moist Heat or Steam Sterilization

[08717213011182]

Moist Heat or Steam Sterilization

[08717213011182]

Moist Heat or Steam Sterilization

[08717213011182]

Moist Heat or Steam Sterilization

[08717213011182]

Moist Heat or Steam Sterilization

[08717213011182]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2022-06-10
• Device Publish Date: 2016-09-10

On-Brand Devices [X-ray Catheters]

• 08717213028555: X-ray Marker 6F 400BC-11
• 08717213028548: X-ray Marker 6F 400BC-10
• 08717213028531: X-ray Marker 6F 400BC-9
• 08717213028524: X-ray Marker 6F 400BC-8
• 08717213028517: X-ray Marker 6F 400BC-7
• 08717213028500: X-ray Marker 6F 400BC-6
• 08717213028494: X-ray Marker 6F 400BC-5
• 08717213028487: X-ray Marker 6F 400BC-4
• 08717213028470: X-ray Marker 6F 400BC-3
• 08717213028456: X-Ray Catheter 50 cm (30)
• 08717213028449: X-Ray Catheter 50 cm (29)
• 08717213028432: X-Ray Catheter 50 cm (28)
• 08717213028425: X-Ray Catheter 50 cm (27)
• 08717213028418: X-Ray Catheter 50 cm (26)
• 08717213028401: X-Ray Catheter 50 cm (25)
• 08717213028395: X-Ray Catheter 50 cm (24)
• 08717213028388: X-Ray Catheter 50 cm (23)
• 08717213028371: X-Ray Catheter 50 cm (22)
• 08717213028364: X-Ray Catheter 50 cm (21)
• 08717213028357: X-Ray Catheter 50 cm (20)
• 08717213028340: X-Ray Catheter 50 cm (19)
• 08717213028333: X-Ray Catheter 30 cm (30)
• 08717213028326: X-Ray Catheter 30 cm (29)
• 08717213028319: X-Ray Catheter 30 cm (28)
• 08717213028302: X-Ray Catheter 30 cm (27)
• 08717213028296: X-Ray Catheter 30 cm (26)
• 08717213028289: X-Ray Catheter 30 cm (25)
• 08717213028272: X-Ray Catheter 30 cm (24)
• 08717213028265: X-Ray Catheter 30 cm (23)
• 08717213028258: X-Ray Catheter 30 cm (22)
• 08717213028241: X-Ray Catheter 30 cm (21)
• 08717213028234: X-Ray Catheter 30 cm (20)
• 08717213028227: X-Ray Catheter 30 cm (19)
• 08717213028210: X-ray marker # 300G-5
• 08717213028203: X-ray marker # 300G-3
• 08717213028197: X-ray marker # 300G-1
• 08717213043312: X-Ray Catheter GYN SS (IU3)
• 08717213028180: X-Ray Catheter GYN SS (O2)
• 08717213028173: X-Ray Catheter GYN SS (O1)
• 08717213028166: X-Ray Catheter GYN SS (R1)
• 08717213043268: X-Ray Catheter CT/MR GYN (IU3)
• 08717213028159: X-Ray Catheter CT/MR GYN (O2)
• 08717213028142: X-Ray Catheter CT/MR GYN (O1)
• 08717213028135: X-Ray Catheter CT/MR GYN (R1)
• 08717213011311: Measuring Wire 30 cm
• 08717213011519: Measuring Wire 50 cm
• 08717213011502: X-Ray Catheter 50 cm (18)
• 08717213011496: X-Ray Catheter 50 cm (17)
• 08717213011489: X-Ray Catheter 50 cm (16)
• 08717213011472: X-Ray Catheter 50 cm (15)