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
Vaginal Cylinder, closed, D=25mm, L=130mm	LA320-74	FDA UDI	Class II	Unknown
RTS Brachytherapy Kit	RTS Brachytherapy Kit	FDA UDI	N/A	Active
Preloaded in PSS1820SL3 Round Hub Needles, 3pk	PSS1820SL3 Round Hub Needles, 3pk	FDA UDI	Class I	Active
Easy Click Transfer Tube 6F, D=3mm, L=1000mm (SagiNova)	LAG1000-6F	FDA UDI	Class II	Unknown
Intrauterine Tube, bent; IUL=60mm	LAR04-01	FDA UDI	Class II	Unknown
AnchorLoad Brachytherapy Kit PD103	AnchorLoad Brachytherapy Kit PD103	FDA UDI	N/A	Active
CT/MR-Vaginal Cylinder, Cervix; D=25mm, L=130mm	LC315-14	FDA UDI	Class II	Unknown
VariLoad Brachytherapy Kit I125	VariLoad Brachytherapy Kit I125	FDA UDI	N/A	Active
Opening Forceps for Fixation Balls	LAH05-02#02	FDA UDI	Class II	Unknown
Ru-106 Eye Applicator, type CCX 6 MBq	RU6.A03	FDA UDI	Class II	Active
Bougie for Oesophagus, single-use, D=12mm (36Fr)	LAZ24-12	FDA UDI	Class II	Unknown
AnchorLoad Brachytherapy Kit I125	AnchorLoad Brachytherapy Kit I125	FDA UDI	N/A	Active
Adapter for Vaginal Cylinder	LC313-22#02	FDA UDI	Class II	Unknown
CT/MR-Applicator for Portio Treatment D=25mm, L=100mm	LCZ04-05	FDA UDI	Class II	Unknown
CT/MR Fletcher Ovoid Tubes right and left	LCT82-02#03	FDA UDI	Class II	Unknown
Universal Applicator incl. plug, D=3mm, L=1400mm	LAA1400-RU	FDA UDI	Class II	Unknown
Dummy, silver, type CCZ	AGD.A21	FDA UDI	Class II	Unknown
Dummy, silver, type CIB-2	AGD.A35	FDA UDI	Class II	Unknown
I-125 Seed	I-125 Seed	FDA UDI	Class II	Active
Vaginal Cylinder with variable length, D=25mm, L=125mm	LAZ07-02#04	FDA UDI	Class II	Unknown
Vaginal Cylinder with variable length, D=30mm, L=130mm	LAZ07-03#04	FDA UDI	Class II	Unknown
Ovoid Tubes, right and left (Fletcher)	LAR72-02	FDA UDI	Class II	Unknown
IU Tube for Ring-Applicator CT/MR, 45°, IUL=60mm	LCT41-8	FDA UDI	Class II	Active
Ru-106 Eye Applicator, type CIB 15 MBq	RU6.A14	FDA UDI	Class II	Active
Dummy, silver, type COE	AGD.A31	FDA UDI	Class II	Active
X-Ray Marker 28, L=325mm	LAH02-28#03	FDA UDI	Class II	Unknown
Fixation cap d=1.6	LLZ10-01	FDA UDI	Class II	Unknown
Flexible Catheter Single Leader, D=1.65mm, L=300mm	LLA300-F#02-5PC	FDA UDI	Class II	Unknown
Dummy, silver, type COC	AGD.A32	FDA UDI	Class II	Active
Echo RTS Brachytherapy Kit PD103	Echo RTS Brachytherapy Kit PD103	FDA UDI	N/A	Active
EchoStrand Brachytherapy Kit PD103	EchoStrand Brachytherapy Kit PD103	FDA UDI	N/A	Active
Shielding Segment 180°	LA320-180#02	FDA UDI	Class II	Unknown
Source Exchange Tube for Container T41, Ir-192	LAZ20-04	FDA UDI	Class II	Unknown
X-Ray Marker 15, L=325mm	LAH02-15#03	FDA UDI	Class II	Unknown
CT/MR Intrauterine Tube 25°, thin, D=3.5mm, IUL=35mm	LCT04-01#03	FDA UDI	Class II	Unknown
Channel Coding for Needles and Catheters (Channel 13)	LLZ03-13	FDA UDI	Class II	Unknown
Ru-106 Eye Applicator with slot, type COB 15 MBq	RU6.A09-S	FDA UDI	Class II	Unknown
Fixation Tube, D=5mm	LC313-21	FDA UDI	Class II	Unknown
IU Tube for Ring-Applicator CT/MR, 45°, IUL=40mm	LCT41-7	FDA UDI	Class II	Unknown
Applicator-Fixation for Bougie D=8mm	LAZ01-08#03	FDA UDI	Class II	Unknown
Dummy, silver, type CIA	AGD.A33	FDA UDI	Class II	Active
CT/MR-Vag. Cylinder with variable length D=40mm L=140mm	LCZ07-05	EUDAMEDFDA UDI	Class II	Active
Plastic Needle, D=1.65mm, L=200mm, 16G	LLA200-KB#02-SP	FDA UDI	Class II	Unknown
SagiNova® Ir, HDR Afterloader, 25 channels, for Ir-192 only	1321-0202	FDA UDI	Class II	Unknown
Vaginal Cylinder with variable length, D=12.5mm, L=120mm	LAZ07-06	FDA UDI	Class II	Unknown
2-Channel-Ring-Applicator CT/MR, 30°, d=35mm	LCT40-3#02	EUDAMEDFDA UDI	Class II	Active
Channel Coding for Needles and Catheters (Channel 6)	LLZ03-06	FDA UDI	Class II	Unknown
Channel Coding for Needles and Catheters (Channel 8)	LLZ03-08	FDA UDI	Class II	Unknown
Ru-106 Eye Applicator, type CCA 10 MBq	RU6.A04	FDA UDI	Class II	Active
Channel Coding for Needles and Catheters (Channel 2)	LLZ03-02	FDA UDI	Class II	Unknown

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