Identity
- Trade Name
- CT Vaginal Segmented Appl Set-closed dome, Varian FDA UDI
- Generic Name
- General-purpose brachytherapy system applicator, manual FDA UDI
- Model / Reference
- 0712-GM FDA UDI
Identifiers
- Catalog Number
- 0712-GM FDA UDI
- Primary DI / UDI-DI
- 00817330021564 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 Vaginal Segmented Appl Set-closed dome, Varian by Mick Radio Nuclear Instrument, Inc — Class II — FDA UDI — listed in FDA GUDID
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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/MR Segmented Vaginal Appl Set, BEBIG — 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 e4487466-0fc4-4154-abdc-3b54076ccab6 34 fields · synced May 31, 2026