Question 1

What types of medical devices does Eckert & Ziegler BEBIG GmbH manufacture?

Accepted Answer

Eckert & Ziegler BEBIG GmbH specializes in manual brachytherapy systems and related components. Their portfolio includes temporary brachytherapy sources, spacers for precise source placement, and implantable radiological image markers. Examples of their products are preloaded needles for I125 seeds, Ru-106 eye applicators, calibration seeds, and dummy sources for training or simulation. They also offer custom marker strands and brachytherapy kits for loose or preloaded seed delivery, designed for targeted radiation therapy.

Question 2

Where is Eckert & Ziegler BEBIG GmbH based, and where are their devices primarily used?

Accepted Answer

Eckert & Ziegler BEBIG GmbH is based in the United States. Their devices are primarily intended for use in the US market, where they are regulated under FDA frameworks. The company’s products are designed for brachytherapy procedures, which are commonly used in radiation oncology for localized treatment of cancers and other conditions.

Question 3

Which regulatory registries list Eckert & Ziegler BEBIG GmbH’s devices?

Accepted Answer

Eckert & Ziegler BEBIG GmbH’s devices are listed in the FDA’s 510(k) premarket notification registry and the FDA’s Unique Device Identifier (UDI) system. These registries track submissions for medical devices regulated under the FDA’s classification system, ensuring compliance with US regulatory requirements for brachytherapy-related products.

Question 4

How are Eckert & Ziegler BEBIG GmbH’s devices classified under FDA regulations?

Accepted Answer

Eckert & Ziegler BEBIG GmbH’s devices fall under FDA classifications of Class I and Class II. Class I devices generally pose minimal risk and are subject to general controls, while Class II devices require special controls to ensure their safety and effectiveness. The classification depends on factors like the device’s intended use, potential risks, and the level of regulation required for safe and effective performance in brachytherapy applications.

Device	Model / Reference	Registries	Class	Status
CT/MR-Vag. Cylinder with variable length D=20mm L=120mm	LCZ07-01#04	FDA UDI	Class II	Unknown
Preloaded in PSS1820SL3 Square Hub Needles, 3pk	PSS1820SL3 Square Hub Needles, 3pk	FDA UDI	Class I	Active
Channel Coding for Needles and Catheters (Channel 16)	LLZ03-16	FDA UDI	Class II	Unknown
Nasopharynx Applicator (Rotterdam Type)	LAZ08	FDA UDI	Class II	Unknown
Spacer 5.5mm Synthetic 150 piece	Spacer 5.5mm Synthetic 150 piece	FDA UDI	Class II	Active
Echo RTS Brachytherapy Kit	Echo RTS Brachytherapy Kit	FDA UDI	N/A	Active
CT/MR Rectal Retractor	LCZ50-01	FDA UDI	Class II	Unknown
Cap, closed, D=25mm	LAZ07-02-00	FDA UDI	Class II	Unknown
Vaginal Cylinder with variable length, D=15mm, L=120mm	LAZ07-07	FDA UDI	Class II	Unknown
X-Ray Marker 27, L=325mm	LAH02-27#03	FDA UDI	Class II	Unknown
Dummy, silver, type COD	AGD.A30	FDA UDI	Class II	Active
Spacer 1cm Synthetic 30 piece	Spacer 1cm Synthetic 30 piece	FDA UDI	Class II	Active
Applicator Clamp with Base Plate	LAZ22-01	FDA UDI	Class II	Unknown
Channel Coding for Needles and Catheters (Channel 10)	LLZ03-10	FDA UDI	Class II	Unknown
CT/MR Holding Discs for gyn. Applicator d=5.0mm D=15mm	LCZ03-01	FDA UDI	Class II	Unknown
Transfer Tube, D=3mm, L=1000mm, QuickFix (SagiNova)	LAF1000#05	FDA UDI	Class II	Unknown
Channel Coding for Needles and Catheters (Channel 9)	LLZ03-09	FDA UDI	Class II	Unknown
Ovoid Tubes, right and left (Manchester)	LAR81-02	FDA UDI	Class II	Unknown
IU Tube for Ring-Applicator CT/MR, 30°, IUL=20mm	LCT40-6	FDA UDI	Class II	Unknown
X-Ray Marker 11, L=325mm	LAH02-11#03	FDA UDI	Class II	Unknown
Intrauterine Tube, CT/MR, bent; IUL=40mm	LCR02-01#02	FDA UDI	Class II	Unknown
X-Ray Marker 23, L=325mm	LAH02-23#03	FDA UDI	Class II	Unknown
Ru-106 Eye Applicator, type CIB-2 15 MBq	RU6.A15	FDA UDI	Class II	Unknown
Channel Coding for Needles and Catheters (Channel 11)	LLZ03-11	FDA UDI	Class II	Unknown
CT/MR Perineal Bar	LCZ51-01	FDA UDI	Class II	Unknown
VariStrand Brachytherapy Kit PD-103	VariStrand Brachytherapy Kit PD-103	FDA UDI	N/A	Active
Ru-106 Eye Applicator, type COD 16 MBq	RU6.A10	FDA UDI	Class II	Active
2-Channel-Ring-Applicator CT/MR, 60°, d=30mm	LCT42-2#02	EUDAMEDFDA UDI	Class II	Active
IU tube for Ring-Applicator CT/MR, 60°, IUL=60mm	LCT42-8#02	EUDAMEDFDA UDI	Class II	Active
Intrauterine Tube, bent; IUL=65mm, 30°	LAR06-01	FDA UDI	Class II	Unknown
Emergency Container for Co-60 or Ir-192	LAC04-03#04	FDA UDI	Class II	Unknown
Channel Coding for Needles and Catheters (Set for Channel 1-20)	LLZ03-21	FDA UDI	Class II	Unknown
Fixation cap d=1.8	LLZ10-02	FDA UDI	Class II	Unknown
2-Channel-Ring-Applicator, 60°, d=30mm; Type Vienna, 5°	LCT43-21	FDA UDI	Class II	Active
Cutter for flexible Catheters	LAH06-01#03	FDA UDI	Class II	Unknown
Vaginal Cylinder with variable length, D=35mm, L=135mm	LAZ07-04#02	FDA UDI	Class II	Unknown
Intrauterine Tube, straight	LAR01-01	FDA UDI	Class II	Unknown
Transfer Tube, D=3mm, L=1000mm, Colour:green, QuickFix (SagiNova)	LAF1000-1#05	FDA UDI	Class II	Unknown
X-Ray Marker 22, L=325mm	LAH02-22#03	FDA UDI	Class II	Unknown
Plastic Needle, D=1.65mm, L=150mm, 16G	LLA150-KB#02-5PC	FDA UDI	Class II	Unknown
Ru-106 Eye Applicator with slot, type CGD 24 MBq	RU6.A07-S	FDA UDI	Class II	Unknown
CT/MR Intrauterine Tube 15°, thin, D=3.5mm, IUL=25mm	LCT02-01#03	FDA UDI	Class II	Unknown
StandardLoad Brachytherapy Kit PD-103	StandardLoad Brachytherapy Kit PD-103	FDA UDI	N/A	Active
2-Channel-Ring-Applicator CT/MR, 30°, d=25mm	LCT40-1#02	FDA UDI	Class II	Unknown
2-Channel-Ring-Applicator, 60°, d=30mm; Type Vienna, 0°	LCT43-2	EUDAMEDFDA UDI	Class II	Active
StandardLoad Brachytherapy Kit I125	StandardLoad Brachytherapy Kit I125	FDA UDI	N/A	Active
Ru-106 Eye Applicator, type CIA 8 MBq	RU6.A13	FDA UDI	Class II	Active
Applicator Brachytherapy Kit	Applicator Brachytherapy Kit I125	FDA UDI	N/A	Active
Vaginal Cylinder with variable length, D=20mm, L=120mm	LAZ07-01#04	FDA UDI	Class II	Unknown
Channel Coding for Needles and Catheters (Channel 4)	LLZ03-04	FDA UDI	Class II	Unknown

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