Identity
- Trade Name
- CT/MR Segmented Vaginal Appl Set, BEBIG FDA UDI
- Generic Name
- General-purpose brachytherapy system applicator, manual FDA UDI
- Model / Reference
- 1406 FDA UDI
Identifiers
- Catalog Number
- 1406 FDA UDI
- Primary DI / UDI-DI
- 00817330023964 FDA UDI
- 510(k) Number
- K001544 FDA UDI
- FDA Product Code
- JAQ FDA UDI
- GMDN Term
- General-purpose brachytherapy system applicator, manual FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.5700 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
No
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 Segmented Vaginal Appl Set, BEBIG by Mick Radio Nuclear Instrument, Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as General-purpose brachytherapy system applicator, manual.
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- TheraSeed® — BARD BRACHYTHERAPY, INC · Class II
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Cleared under the same submission
K001544 also covers:
- Build-Up Segment - 2.0cm Dia. CT Seg Vag Appl — MICK RADIO NUCLEAR INSTRUMENT, INC
- CT Vaginal Segmented Appl Set-closed dome, Nucltrn — MICK RADIO NUCLEAR INSTRUMENT, INC
- CT Vaginal Segmented Appl Set-closed dome, Varian — MICK RADIO NUCLEAR INSTRUMENT, INC
- CT/MR Segmented Vaginal Appl Set, Varian — MICK RADIO NUCLEAR INSTRUMENT, INC
- CT/MR Segmented Vaginal IU tube, eng. 2.0, Bebig — MICK RADIO NUCLEAR INSTRUMENT, INC
- CT/MR Segmented Vaginal IU tube, eng. 2.3, Bebig — MICK RADIO NUCLEAR INSTRUMENT, INC
- CT/MR Segmented Vaginal IU tube, eng. 2.6, Bebig — MICK RADIO NUCLEAR INSTRUMENT, INC
- CT/MR Segmented Vaginal IU tube, eng. 3.0, Bebig — MICK RADIO NUCLEAR INSTRUMENT, INC
- CT/MR Segmented Vaginal IU tube, eng. 3.5, Bebig — MICK RADIO NUCLEAR INSTRUMENT, INC
- CT/MR Segmented Vaginal IU tube, eng. 4.0, Bebig — MICK RADIO NUCLEAR INSTRUMENT, INC
- Cylinder Set, 2.0cm, CT Seg Vag - closed dome — MICK RADIO NUCLEAR INSTRUMENT, INC
- Cylinder Set, 2.3cm, CT Seg Vag - closed dome — MICK RADIO NUCLEAR INSTRUMENT, INC
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| 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 (1)
- FDA UDI 9277903e-6714-45ba-9c20-8630bc03ef85 34 fields · synced May 30, 2026