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
Dummy, silver, type COB	AGD.A29	FDA UDI	Class II	Active
Ru-106 Eye Applicator with slot, type CIB 18.9 MBq	RU6.A14-S	FDA UDI	Class II	Unknown
I125 Calibration Seed	I125 Calibration Seed	FDA UDI	Class II	Active
X-Ray Marker 13, L=325mm	LAH02-13#03	FDA UDI	Class II	Unknown
IU Tube for Ring-Applicator CT/MR, 30°, IUL=60mm	LCT40-8	FDA UDI	Class II	Unknown
Fixation cap d=7.1	LLZ10-03	FDA UDI	Class II	Unknown
Ru-106 Eye Applicator with slot, type CCD 14 MBq	RU6.A05-S	FDA UDI	Class II	Unknown
VariLoad Brachytherapy Kit	VariLoad Brachytherapy Kit	FDA UDI	N/A	Active
Breast Template, triple plane, 8mm (Paris) without Button	LLZ21-08	FDA UDI	Class II	Unknown
IU tube for Ring-Applicator CT/MR, 60°, IUL=20mm	LCT42-6#02	FDA UDI	Class II	Unknown
PD-103 Seed	PD-103 Seed	FDA UDI	N/A	Active
Echo RTS Brachytherapy Kit I-125	Echo RTS Brachytherapy Kit I-125	FDA UDI	N/A	Active
X-Ray Marker with Ruler 10:10, d=1.2 mm, L=1230mm	LLH02-21#04	FDA UDI	Class II	Unknown
Spacer 5.5mm Synthetic 50 piece	Spacer 5.5mm Synthetic 50 piece	FDA UDI	Class II	Active
CT/MR Holding Discs for gyn. Applicator, d=3.5mm D=15mm	LCZ03-03	FDA UDI	Class II	Unknown
Ru-106 Eye Applicator without ears, type CCB 19 MBq	RU6.A06-E	FDA UDI	Class II	Unknown
Ru-106 Eye Applicator, type CCB 19 MBq	RU6.A06	FDA UDI	Class II	Active
AnchorLoad Brachytherapy Kit	AnchorLoad Brachytherapy Kit	FDA UDI	N/A	Active
2-Channel-Ring-Applicator CT/MR, 45°, d=25mm	LCT41-1#02	FDA UDI	Class II	Unknown
Intrauterine Tube, bent; IUL=50mm	LAR03-01	FDA UDI	Class II	Unknown
Breast Template, triple plane, 16mm (Paris) with Button	LLZ20-16	FDA UDI	Class II	Unknown
Channel Coding for Transfer Tubes (Set for Channel 1-20)	LLZ04-01	FDA UDI	Class II	Unknown
Dummy, silver, type CCB	AGD.A26	FDA UDI	Class II	Active
Endometrium-Applicator CT/MR, D=5mm	LCR70-01#02	FDA UDI	Class II	Unknown
Ru-106 Eye Applicator, type COB 15 MBq	RU6.A09	FDA UDI	Class II	Active
X-Ray Marker 19, L=325mm	LAH02-19#03	FDA UDI	Class II	Unknown
Dummy, silver, type CCY	AGD.A22	FDA UDI	Class II	Unknown
IU Tube for Ring-Applicator CT/MR, D=3.5mm L=60mm	LCT06-02	FDA UDI	Class II	Unknown
Vaginal Cylinder, closed, D=22mm, L=130mm	LA320-64	FDA UDI	Class II	Unknown
Vaginal Cylinder with variable length, D=40mm, L=140mm	LAZ07-05#02	FDA UDI	Class II	Unknown
Applicator Brachytherapy Kit	Applicator Brachytherapy Kit PD103	FDA UDI	N/A	Active
SagiPlan® 2.x Software	1374-0600#03	FDA UDI	Class II	Unknown
Intrauterine Tube, CT/MR, straight	LCR01-01#02	FDA UDI	Class II	Unknown
SagiPlan® V.2.x Prostate Module Add-on SW	1374-0610#01	FDA UDI	Class II	Unknown
EchoStrand Brachytherapy Kit	EchoStrand Brachytherapy Kit	FDA UDI	N/A	Active
RTS Brachytherapy Kit PD103	RTS Brachytherapy Kit PD103	FDA UDI	N/A	Active
Connector for Universal Applicator, d=2mm	LLS50	FDA UDI	Class II	Unknown
Ru-106 Eye Applicator, type COC 27 MBq	RU6.A12	FDA UDI	Class II	Active
Breast Template, triple plane, 12mm (Paris) with Button	LLZ20-12	FDA UDI	Class II	Unknown
Intrauterine Tube, CT/MR, bent; IUL=65mm, 30°	LCR06-01#02	FDA UDI	Class II	Unknown
Intrauterine Tube, CT/MR, bent; IUL=50mm	LCR03-01#02	FDA UDI	Class II	Unknown
AnchorLoad Brachytherapy Kit PD103 - Loose Load	AnchorLoad Brachytherapy Kit PD103 - Loose Load	FDA UDI	N/A	Active
Vaginal Cylinder, closed, D=35mm, L=130mm	LA320-89	FDA UDI	Class II	Unknown
X-Ray Marker 18, L=325mm	LAH02-18#03	FDA UDI	Class II	Unknown
Marker Seed - Preloaded in PSS1820SL3 Round Hub Needles, Single Pack	PSS1820SL3 Round Hub Needles, Single Pack	FDA UDI	Class I	Active
Flexible Catheter Blind End, D=1.65mm, L=300mm	LLA300-FB#02-SP	FDA UDI	Class II	Unknown
CT/MR Cap, closed, D=25mm	LCZ07-02-00	FDA UDI	Class II	Unknown
Breast Template, triple plane, 20mm (Paris) with Button	LLZ20-20	FDA UDI	Class II	Unknown
Plastic Needle, D=1.65mm, L=300mm, 16G	LLA300-KB#02-SP	FDA UDI	Class II	Unknown
CT/MR-Vag. Cylinder with variable length D=15mm L=120mm	LCZ07-07	FDA UDI	Class II	Unknown

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