Disposable steel needle, 17G, L=200mm LLA210-S

GUDID 04065983002850

The Disposable Steel Needles are intended for interstitial brachytherapy applications.

BEBIG Medical GmbH

Remote-afterloading brachytherapy system

• Primary Device ID: 04065983002850
• NIH Device Record Key: 08455a2d-254d-4523-b8f8-74eb5b3e570e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Disposable steel needle, 17G, L=200mm
• Version Model Number: 05
• Catalog Number: LLA210-S
• Company DUNS: 343363100
• Company Name: BEBIG Medical GmbH
• Device Count: 20
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04065983000962 [Unit of Use]
GS1	04065983002850 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142986

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: 2024-09-26
• Device Publish Date: 2024-09-18

Devices Manufactured by BEBIG Medical GmbH

• 04065983002850 - Disposable steel needle, 17G, L=200mm: 2024-09-26The Disposable Steel Needles are intended for interstitial brachytherapy applications.
• 04065983002850 - Disposable steel needle, 17G, L=200mm: 2024-09-26 The Disposable Steel Needles are intended for interstitial brachytherapy applications.
• 04065983000986 - Transfer Tube, D=3mm, L=1000mm: 2024-05-06 The Transfer Tubes and Couplings are intended for connecting HDR applicators to the treatment delivery unit (TDU).
• 04065983000993 - Transfer Tube, D=3mm, L=1000mm, Green, Channel 1: 2024-05-06 The Transfer Tubes and Couplings are intended for connecting HDR applicators to the treatment delivery unit (TDU).
• 04065983001006 - Transfer Tube, D=3mm, L=1000mm, Yellow, Channel 2: 2024-05-06 The Transfer Tubes and Couplings are intended for connecting HDR applicators to the treatment delivery unit (TDU).
• 04065983001013 - Transfer Tube, D=3mm, L=1000mm, Blue, Channel 3: 2024-05-06 The Transfer Tubes and Couplings are intended for connecting HDR applicators to the treatment delivery unit (TDU).
• 04065983001020 - Transfer Tube, D=3mm, L=1000mm, T-connector: 2024-05-06 The Transfer Tubes and Couplings are intended for connecting HDR applicators to the treatment delivery unit (TDU).
• 04065983001037 - Transfer Tube, D=3mm, L=1000mm, Green, Channel 1, T-connector: 2024-05-06 The Transfer Tubes and Couplings are intended for connecting HDR applicators to the treatment delivery unit (TDU).
• 04065983001044 - Transfer Tube, D=3mm, L=1000mm, Yellow, Channel 2, T-connector: 2024-05-06 The Transfer Tubes and Couplings are intended for connecting HDR applicators to the treatment delivery unit (TDU).