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CT/MR Ring & Tandem Appl Set 26mm, BEBIG
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref 1402
Identity
- Trade Name
- CT/MR 26mm Ring & Tandem Applicator Set - BEBIG EUDAMEDCT/MR Ring & Tandem Appl Set 26mm, BEBIG FDA UDI
- Generic Name
- General-purpose brachytherapy system applicator, manual FDA UDI
- Device Name
- CT/MR Ring & Tandem Applicator EUDAMED
- Model / Reference
- 1402 EUDAMEDFDA UDI
Identifiers
- Catalog Number
- 1402 FDA UDI
- Primary DI / UDI-DI
- 00817330023926 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00817330023926 EUDAMED
- 510(k) Number
- K030110 FDA UDI
- FDA Product Code
- JAQ FDA UDI
- EMDN Code
- Z11010380 BRACHYTHERAPY RADIATION SYSTEMS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- General-purpose brachytherapy system applicator, manual FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 892.5700 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Safe FDA UDI
Category: General-purpose brachytherapy system applicator, manual
CT/MR Ring & Tandem Appl Set 26mm, BEBIG by Mick Radio Nuclear Instrument, Inc — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED
Similar devices
Also classified as General-purpose brachytherapy system applicator, manual.
- AccuBoost — ADVANCED RADIATION THERAPY, LLC · Class I
- AccuBoost® — ADVANCED RADIATION THERAPY, LLC · Class II
- AccuBoost® — ADVANCED RADIATION THERAPY, LLC · Class II
- TheraSeed® — BARD BRACHYTHERAPY, INC · Class II
- AccuBoost® — ADVANCED RADIATION THERAPY, LLC · Class II
- Best Medical International — Best Medical International, Inc. · Class I
- Buttons — LIBERTY MEDICAL INC · Class I
- Adapter — LIBERTY MEDICAL INC · Class I
Cleared under the same submission
K030110 also covers:
- 5.0mm Build Up Caps, single-use, Split-Ring (6pc) — MICK RADIO NUCLEAR INSTRUMENT, INC
- BuildUP Cap for Rng & Tand, 7.5mm (white) — MICK RADIO NUCLEAR INSTRUMENT, INC
- CT Vaginal Cylinder, 35mm cylinder — MICK RADIO NUCLEAR INSTRUMENT, INC
- CT/MR R&T IU Tube, 30ø, 10.0cm, Nucletron — MICK RADIO NUCLEAR INSTRUMENT, INC
- CT/MR R&T IU Tube, 30ø, 2.0cm, Nucletron — MICK RADIO NUCLEAR INSTRUMENT, INC
- CT/MR R&T IU Tube, 30ø, 4.0cm, Nucletron — MICK RADIO NUCLEAR INSTRUMENT, INC
- CT/MR R&T IU Tube, 30ø, 7.0cm, Nucletron — MICK RADIO NUCLEAR INSTRUMENT, INC
- CT/MR R&T IU Tube, 30ø, 8.0cm, Nucletron — MICK RADIO NUCLEAR INSTRUMENT, INC
- CT/MR R&T IU Tube, 45ø, 10.0cm, Nucletron — MICK RADIO NUCLEAR INSTRUMENT, INC
- CT/MR R&T IU Tube, 45ø, 2.0cm, Nucletron — MICK RADIO NUCLEAR INSTRUMENT, INC
- CT/MR R&T IU Tube, 45ø, 4.0cm, Nucletron — MICK RADIO NUCLEAR INSTRUMENT, INC
- CT/MR R&T IU Tube, 45ø, 5.0cm, Nucletron — MICK RADIO NUCLEAR INSTRUMENT, INC
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Mick Radio Nuclear Instrument, Inc
Sources (2)
- FDA UDI 57039ee8-7a88-4624-81de-5215dd2069cb 34 fields · synced Jul 11, 2026
- EUDAMED 8ba00e87-685b-43d8-92e0-2f5b600ad6e6 61 fields · synced Jul 11, 2026