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CT/MR Split-Ring Applicator, 32mm, 60ø Set, Bebig
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref 1401
Identity
- Trade Name
- CT/MR Split Ring Applicator Set - BEBIG EUDAMEDCT/MR Split-Ring Applicator, 32mm, 60ø Set, Bebig FDA UDICT/MR Split-Ring Appl Combo Set, BEBIG FDA UDI
- Generic Name
- General-purpose brachytherapy system applicator, manual FDA UDI
- Device Name
- CT/MR Split Ring GYN Applicator EUDAMED
- Model / Reference
- 1401 EUDAMEDFDA UDI1401-60 FDA UDI
Identifiers
- Catalog Number
- 1401-60 FDA UDI1401 FDA UDI
- Primary DI / UDI-DI
- 00817330023704 EUDAMEDFDA UDI00817330023858 FDA UDI
- Basic UDI-DI
- B-00817330023704 EUDAMED
- 510(k) Number
- K063382 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 Split-Ring Applicator, 32mm, 60ø Set, 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
K063382 also covers:
- CT/MR 2/3 Channel Endom. Appl Set, BEBIG — MICK RADIO NUCLEAR INSTRUMENT, INC
- CT/MR Spit-Rng B-U, 7.5mmx5.0mm, reus, SET — MICK RADIO NUCLEAR INSTRUMENT, INC
- CT/MR Split-Ring 4cm IU Tube, 45ø Bebig — MICK RADIO NUCLEAR INSTRUMENT, INC
- CT/MR Split-Ring Appl, 60ø Set, Nucletron — MICK RADIO NUCLEAR INSTRUMENT, INC
- CT/MR Split-Ring Applicator Set, 30ø Set, Bebig — MICK RADIO NUCLEAR INSTRUMENT, INC
- CT/MR Split-Ring Applicator Set, 32mm, 45ø, Varian — MICK RADIO NUCLEAR INSTRUMENT, INC
- CT/MR Split-Ring Applicator Set, 45ø, Nucletron — MICK RADIO NUCLEAR INSTRUMENT, INC
- CT/MR Split-Ring Applicator, 45ø Set, Bebig — MICK RADIO NUCLEAR INSTRUMENT, INC
- CT/MR Split-Ring Colpostat Left, 45ø Bebig — MICK RADIO NUCLEAR INSTRUMENT, INC
- CT/MR Split-Ring Colpostat Left, 45ø, Varian — MICK RADIO NUCLEAR INSTRUMENT, INC
- CT/MR Split-Ring Colpostat Right, 30ø Bebig — MICK RADIO NUCLEAR INSTRUMENT, INC
- CT/MR Split-Ring Colpostat Right, 45ø, Varian — 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 (3)
- FDA UDI b5647a95-22c0-4979-9071-d82a975f5201 34 fields · synced Jul 22, 2026
- FDA UDI 05c9cc10-634f-44db-bbda-6dc63c9ab2fa 34 fields · synced May 30, 2026
- EUDAMED 0a713156-17bc-4e00-80cb-e96babd3b5a7 61 fields · synced Jul 22, 2026