X-ray Catheters

GUDID 08717213028173

X-Ray Catheter GYN SS (O1)

Nucletron B.V.

Imaging lesion localization marker, implantable

• Primary Device ID: 08717213028173
• NIH Device Record Key: e19b04c5-b5d8-4833-9a1a-05b199c20921
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: X-ray Catheters
• Version Model Number: 110572P01-00
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	08717213028173 [Direct Marking]
GS1	08717213043282 [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

[08717213028173]

Moist Heat or Steam Sterilization

[08717213028173]

Moist Heat or Steam Sterilization

[08717213028173]

Moist Heat or Steam Sterilization

[08717213028173]

Moist Heat or Steam Sterilization

[08717213028173]

Moist Heat or Steam Sterilization

[08717213028173]

Moist Heat or Steam Sterilization

[08717213028173]

Moist Heat or Steam Sterilization

[08717213028173]

Moist Heat or Steam Sterilization

[08717213028173]

Moist Heat or Steam Sterilization

[08717213028173]

Moist Heat or Steam Sterilization

[08717213028173]

Moist Heat or Steam Sterilization

[08717213028173]

Moist Heat or Steam Sterilization

[08717213028173]

Moist Heat or Steam Sterilization

[08717213028173]

Moist Heat or Steam Sterilization

[08717213028173]

Moist Heat or Steam Sterilization

[08717213028173]

Moist Heat or Steam Sterilization

[08717213028173]

Moist Heat or Steam Sterilization

[08717213028173]

Moist Heat or Steam Sterilization

[08717213028173]

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)