Identity
- Trade Name
- CT/MR Fletcher (FSD) Colpostat, Left, Bebig FDA UDI
- Generic Name
- General-purpose brachytherapy system applicator, manual FDA UDI
- Model / Reference
- 1409-04L FDA UDI
Identifiers
- Catalog Number
- 1409-04L FDA UDI
- Primary DI / UDI-DI
- 00817330024053 FDA UDI
- 510(k) Number
- K063381 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 Fletcher (FSD) Colpostat, Left, 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
- AccuBoost® — ADVANCED RADIATION THERAPY, LLC · Class II
- Best Medical International — Best Medical International, Inc. · Class I
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Cleared under the same submission
K063381 also covers:
- CT/MR FSD Colpostat w/ Brack, Right, Varian — MICK RADIO NUCLEAR INSTRUMENT, INC
- CT/MR FSD Colpostat w/ Bracket, Left, Varian — MICK RADIO NUCLEAR INSTRUMENT, INC
- CT/MR FSD Colpostat w/ Bracket, Right, Nucletron — MICK RADIO NUCLEAR INSTRUMENT, INC
- CT/MR FSD Colpostat w/ Bracket., Left, Nucletron — MICK RADIO NUCLEAR INSTRUMENT, INC
- CT/MR FSD Ovoid Pair, 2.0cm diam — MICK RADIO NUCLEAR INSTRUMENT, INC
- CT/MR FSD Ovoid Pair, 2.5cm diam — MICK RADIO NUCLEAR INSTRUMENT, INC
- CT/MR FSD Ovoid Pair, 3.0cm diam — MICK RADIO NUCLEAR INSTRUMENT, INC
- CT/MR FSD Ovoid Pair, 3.0cm diam — MICK RADIO NUCLEAR INSTRUMENT, INC
- CT/MR Fletcher (FSD) Appl Set, Nucletron — MICK RADIO NUCLEAR INSTRUMENT, INC
- CT/MR Fletcher (FSD) Appl. Set, Varian — MICK RADIO NUCLEAR INSTRUMENT, INC
- CT/MR Fletcher (FSD) Appl. Set, Varian — MICK RADIO NUCLEAR INSTRUMENT, INC
- CT/MR Fletcher (FSD) Applicator Set, BEBIG — 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Mick Radio Nuclear Instrument, Inc
Sources (1)
- FDA UDI dfc00405-b82e-4b95-8ee2-1e79e984d454 34 fields · synced May 30, 2026