Advanced Gynecological Applicator

GUDID 08717213054318

Bracelet For Guiding Tubes

Nucletron B.V.

Cervical/intrauterine brachytherapy system applicator, remote-afterloading

• Primary Device ID: 08717213054318
• NIH Device Record Key: 71411cb5-14d3-465e-b487-b099ccfe5d61
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Advanced Gynecological Applicator
• Version Model Number: 126060-01
• 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: 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	08717213053977 [Primary]
GS1	08717213054318 [Package]; Contains: 08717213053977; Package: [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161688

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-02-06
• Device Publish Date: 2020-01-29

On-Brand Devices [Advanced Gynecological Applicator]

• 08717213054325: Number Tags For Guiding Tubes
• 08717213054318: Bracelet For Guiding Tubes
• 08717213054790: Interstitial Lunar Ovoid Tube 26mm 60° Right
• 08717213054783: Interstitial Lunar Ovoid Tube 22mm 60° Left
• 08717213054776: Interstitial Lunar Ovoid Tube 22mm 60° Right
• 08717213055032: Intrauterine Tube 40mm 30°
• 08717213054899: Intrauterine Tube 30mm 30°
• 08717213054882: Intrauterine Tube 0mm
• 08717213054813: Interstitial Lunar Ovoid Tube 30mm 60° Left
• 08717213054806: Interstitial Lunar Ovoid Tube 30mm 60° Right
• 08717213054752: Interstitial Lunar Ovoid Tube 26mm 60° Left
• 08717213054905: Vaginal Cap 30mm Left
• 08717213054912: Vaginal Cap 30mm Right
• 08717213054929: Vaginal Cap 26mm Left
• 08717213055797: Vaginal Cap 26mm Right
• 08717213055773: Vaginal Cap 22mm Left
• 08717213055742: Vaginal Cap 22mm Right
• 08717213055643: Interstitial lever
• 08717213055629: Perineal Bar
• 08717213055599: Perineal Template Ventral 0°
• 08717213055575: Perineal Template Dorsal 12°
• 08717213055551: Perineal Template Dorsal 0°
• 08717213055544: Fixation Clip
• 08717213055513: Fixation Element
• 08717213054844: Intrauterine Tube 70mm 15°
• 08717213055124: Intrauterine Tube 60mm 15°
• 08717213054820: Intrauterine Tube 50mm 15°
• 08717213054868: Intrauterine Tube 40mm 15°
• 08717213054875: Intrauterine Tube 30mm 15°
• 08717213055070: Intrauterine Tube 70mm 30°
• 08717213054851: Intrauterine Tube 60mm 30°
• 08717213054837: Intrauterine Tube 50mm 30°