Connector for Universal Applicator, D=2.0mm (EasyClick 6F) LLS50-6F

GUDID 04065983001082

BEBIG Medical GmbH

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Primary Device ID	04065983001082
NIH Device Record Key	08fa8f75-1a5d-4adf-aa8f-628b82a5c25b
Commercial Distribution Status	In Commercial Distribution
Brand Name	Connector for Universal Applicator, D=2.0mm (EasyClick 6F)
Version Model Number	01
Catalog Number	LLS50-6F
Company DUNS	343363100
Company Name	BEBIG Medical GmbH
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	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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04065983001082 [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	false

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2024-05-06
Device Publish Date	2024-04-26

Devices Manufactured by BEBIG Medical GmbH

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).
04065983001051 - Transfer Tube, D=3mm, L=1000mm, Blue, Channel 3, T-connector	2024-05-06 The Transfer Tubes and Couplings are intended for connecting HDR applicators to the treatment delivery unit (TDU).