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
Holder for Fixation Cap, subglossal	LAH04-02	FDA UDI	Class II	Unknown
Adapter 5.0mm - 6.5mm	LCZ08-01#02	FDA UDI	Class II	Unknown
Custom MarkerStrand - Two Gold Marker preloaded in PSS1820SLS Round Hub Needle	PSS1820SLS Round Hub Needle	FDA UDI	Class I	Active
AnchorLoad Brachytherapy Kit - Loose Load	AnchorLoad Brachytherapy Kit - Loose Load	FDA UDI	N/A	Active
Ru-106 Eye Applicator, type CXS 4 MBq	RU6.A033	FDA UDI	Class II	Active
Dummy, silver, type CCA	AGD.A24	FDA UDI	Class II	Active
CT/MR-Vag. Cylinder with variable length D=12.5mm L=120mm	LCZ07-06	FDA UDI	Class II	Unknown
X-Ray Marker 24, L=325mm	LAH02-24#03	FDA UDI	Class II	Unknown
X-Ray Marker 12, L=325mm	LAH02-12#03	FDA UDI	Class II	Unknown
Channel Coding for Needles and Catheters (Channel 19)	LLZ03-19	FDA UDI	Class II	Unknown
VariStrand Brachytherapy Kit I125	VariStrand Brachytherapy Kit I125	FDA UDI	N/A	Active
Channel Coding for Needles and Catheters (Channel 12)	LLZ03-12	FDA UDI	Class II	Unknown
Reconstruction Box for small C-Arm	LAZ11-04#02	FDA UDI	Class II	Unknown
SagiPlan® 2.x Software	1374-0600#01	FDA UDI	Class II	Unknown
Preloaded in PSS1820SL3 Round Hub Needles, Single Pack	PSS1820SL3 Round Hub Needles, Single Pack	FDA UDI	Class I	Active
Screwdriver 2.0 mm	LAZ09-02#02	FDA UDI	Class II	Unknown
CT/MR Intrauterine Tube 30°, thin, D=3.5mm, IUL=65mm	LCT06-01#03	FDA UDI	Class II	Unknown
Universal Applicator incl. plug, D=3mm, L=1400mm (non sterile)	LAA1400-GYN	FDA UDI	Class II	Unknown
X-Ray Marker 17, L=325mm	LAH02-17#03	FDA UDI	Class II	Unknown
Flexible Catheter Single Leader, D=1.65mm, L=300mm	LLA300-F#02-SP	FDA UDI	Class II	Unknown
IsoSeed® I-125, unsterile, loose, high activity	I25.S17PLUS-ULH	FDA UDI	Class II	Unknown
Channel Coding for Needles and Catheters (Channel 15)	LLZ03-15	FDA UDI	Class II	Unknown
SagiNova®, HDR Afterloader, 25 channels, for Co-60 and Ir-192	1321-0201	FDA UDI	Class II	Unknown
X-Ray Marker 25, L=325mm	LAH02-25#03	FDA UDI	Class II	Unknown
Universal Applicator incl. plug, D=3mm, L=1400mm (non sterile)	LAA1400-GYN#02	FDA UDI	Class II	Unknown
Easy Click Transfer Tube, D=3mm, L=1000mm	LAG1000#02	FDA UDI	Class II	Unknown
X-Ray Marker with Ruler 10:10, d=1.2 mm, L=1430mm	LLH02-11#04	FDA UDI	Class II	Unknown
Channel Coding for Needles and Catheters (Channel 14)	LLZ03-14	FDA UDI	Class II	Unknown
IU Tube for Ring-Applicator CT/MR, 30°, IUL=40mm	LCT40-7	FDA UDI	Class II	Unknown
Ru-106 Eye Applicator, type CCZ 6 MBq	RU6.A01	FDA UDI	Class II	Unknown
AnchorLoad Brachytherapy Kit I125 - Loose Load	AnchorLoad Brachytherapy Kit I125 - Loose Load	FDA UDI	N/A	Active
Universal Applicator, marked, D=2mm, L=1200mm (sterile)	LLA1200-20#04	FDA UDI	Class II	Unknown
2-Channel-Ring-Applicator CT/MR, 45°, d=35mm	LCT41-3#02	FDA UDI	Class II	Unknown
Bougie for Oesophagus, single-use, D=8mm (24Fr)	LAZ24-08	FDA UDI	Class II	Unknown
X-Ray Marker 14, L=325mm	LAH02-14#03	FDA UDI	Class II	Unknown
Flexible Catheter Blind End, D=1.65mm, L=300mm	LLA300-FB#02-5PC	FDA UDI	Class II	Unknown
Ru-106 Eye Applicator, type CGD 24 MBq	RU6.A07	FDA UDI	Class II	Active
Holder for Fixation Cap, glossal	LAH04-01	FDA UDI	Class II	Unknown
CT/MR Intrauterine Tube 40°, thin, D=3.5mm, IUL=35mm	LCT05-01#03	FDA UDI	Class II	Unknown
Breast Template, triple plane, 16mm (Paris) without Button	LLZ21-16	FDA UDI	Class II	Unknown
Transfer Tube, D=3mm, L=1000mm, Colour:blue, QuickFix (SagiNova)	LAF1000-3#05	FDA UDI	Class II	Unknown
Ru-106 Eye Applicator, type CCY 6 MBq	RU6.A02	FDA UDI	Class II	Unknown
Breast Template, triple plane, 12mm (Paris) without Button	LLZ21-12	FDA UDI	Class II	Unknown
AnchorSeed Brachytherapy Kit	AnchorSeed Brachytherapy Kit	FDA UDI	N/A	Active
Intrauterine Tube, bent; IUL=40mm	LAR02-01	FDA UDI	Class II	Unknown
CT/MR-Applicator for Portio Treatment D=30mm, L=100mm	LCZ04-15	FDA UDI	Class II	Unknown
Ru-106 Eye Applicator with slot, type CCA 10 MBq	RU6.A04-S	FDA UDI	Class II	Unknown
CT/MR Obturator for Plastic Needle, L= 300 mm (à 1 pc)	LLH02-300	FDA UDI	Class II	Unknown
CT/MR-Vag. Cylinder with variable length D=25mm L=125mm	LCZ07-02#04	FDA UDI	Class II	Unknown
CT/MR-Vaginal Cylinder, Cervix; D=30mm, L=130mm	LC315-24	FDA UDI	Class II	Unknown

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