Geneva

GUDID 08717213055988

Intrauterine Tube 0mm

Nucletron B.V.

Cervical/intrauterine brachytherapy system applicator, remote-afterloading Cervical/intrauterine brachytherapy system applicator, remote-afterloading Cervical/intrauterine brachytherapy system applicator, remote-afterloading Cervical/intrauterine brachytherapy system applicator, remote-afterloading Cervical/intrauterine brachytherapy system applicator, remote-afterloading Cervical/intrauterine brachytherapy system applicator, remote-afterloading Cervical/intrauterine brachytherapy system applicator, remote-afterloading Cervical/intrauterine brachytherapy system applicator, remote-afterloading Cervical/intrauterine brachytherapy system applicator, remote-afterloading Cervical/intrauterine brachytherapy system applicator, remote-afterloading Cervical/intrauterine brachytherapy system applicator, remote-afterloading Cervical/intrauterine brachytherapy system applicator, remote-afterloading Cervical/intrauterine brachytherapy system applicator, remote-afterloading Cervical/intrauterine brachytherapy system applicator, remote-afterloading Cervical/intrauterine brachytherapy system applicator, remote-afterloading

• Primary Device ID: 08717213055988
• NIH Device Record Key: 56e3884b-f809-4c00-8bfe-b3ed4f192e1d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Geneva
• Version Model Number: 152005-00
• Company DUNS: 415269930
• Company Name: Nucletron B.V.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	08717213055988 [Direct Marking]
GS1	08717213055995 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201272

FDA Product Code

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

Sterilization

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

[08717213055988]

Moist Heat or Steam Sterilization

[08717213055988]

Moist Heat or Steam Sterilization

[08717213055988]

Moist Heat or Steam Sterilization

[08717213055988]

Moist Heat or Steam Sterilization

[08717213055988]

Moist Heat or Steam Sterilization

[08717213055988]

Moist Heat or Steam Sterilization

[08717213055988]

Moist Heat or Steam Sterilization

[08717213055988]

Moist Heat or Steam Sterilization

[08717213055988]

Moist Heat or Steam Sterilization

[08717213055988]

Moist Heat or Steam Sterilization

[08717213055988]

Moist Heat or Steam Sterilization

[08717213055988]

Moist Heat or Steam Sterilization

[08717213055988]

Moist Heat or Steam Sterilization

[08717213055988]

Moist Heat or Steam Sterilization

[08717213055988]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-08-21
• Device Publish Date: 2020-08-13

On-Brand Devices [Geneva]

• 08717213055902: Ovoid Tube 1
• 08717213056381: Intrauterine Tube 70mm 15°
• 08717213055988: Intrauterine Tube 0mm
• 08717213055964: Ovoid Tube 2 - Interstitial Ovoid 13mm
• 08717213055940: Ovoid Tube 1 - Interstitial Ovoid 13mm
• 08717213056787: Tubes Locking Clip
• 08717213056640: Intrauterine Tube 80mm 45°
• 08717213056626: Intrauterine Tube 70mm 45°
• 08717213056602: Intrauterine Tube 60mm 45°
• 08717213056589: Intrauterine Tube 50mm 45°
• 08717213056565: Intrauterine Tube 40mm 45°
• 08717213056541: Intrauterine Tube 30mm 45°
• 08717213056527: Intrauterine Tube 80mm 30°
• 08717213056503: Intrauterine Tube 70mm 30°
• 08717213056480: Intrauterine Tube 60mm 30°
• 08717213056466: Intrauterine Tube 50mm 30°
• 08717213056442: Intrauterine Tube 40mm 30°
• 08717213056428: Intrauterine Tube 30mm 30°
• 08717213056404: Intrauterine Tube 80mm 15°
• 08717213056374: Spreading Clip
• 08717213056367: Spreading Clip - Bolt
• 08717213056350: Spreading Clip - Clip 1
• 08717213056329: Rectal Retractor 40mm
• 08717213056305: Rectal Retractor 30mm
• 08717213056282: Rectal Retractor 20mm
• 08717213056275: Interstitial Ovoid Pair 40mm
• 08717213056268: Interstitial Ovoid 40mm 1
• 08717213056251: Interstitial Ovoid 40mm 2
• 08717213056244: Interstitial Ovoid Pair 35mm
• 08717213056237: Interstitial Ovoid 35mm 1
• 08717213056220: Interstitial Ovoid 35mm 2
• 08717213056213: Interstitial Ovoid Pair 30mm
• 08717213056190: Interstitial Ovoid 30mm 2
• 08717213056183: Interstitial Ovoid Pair 25mm
• 08717213056176: Interstitial Ovoid 25mm 1
• 08717213056169: Interstitial Ovoid 25mm 2
• 08717213056152: Interstitial Ovoid Pair 20mm
• 08717213056145: Interstitial Ovoid 20mm 1
• 08717213056138: Interstitial Ovoid 20mm 2
• 08717213056121: Interstitial Ovoid Pair 15mm
• 08717213056114: Interstitial Ovoid 15mm 1
• 08717213056107: Interstitial Ovoid 15mm 2
• 08717213056084: Intrauterine Tube 60mm 15°
• 08717213056060: Intrauterine Tube 50mm 15°
• 08717213056046: Intrauterine Tube 40mm 15°
• 08717213056022: Intrauterine Tube 30mm 15°
• 08717213056008: Interstitial Tube
• 08717213055926: Ovoid Tube 2