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CT/MR Henschke Applicator Set, Varian
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref 0508
Identity
- Trade Name
- CT/MR Henschke Applicator Set - Varian EUDAMEDCT/MR Henschke Applicator Set, Varian FDA UDI
- Generic Name
- Cervical/intrauterine brachytherapy system applicator, manual FDA UDI
- Device Name
- CT/MR Henschke GYN Applicator EUDAMED
- Model / Reference
- 0508 EUDAMEDFDA UDI
Identifiers
- Catalog Number
- 0508 FDA UDI
- Primary DI / UDI-DI
- 00817330020819 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00817330020819 EUDAMED
- 510(k) Number
- K040704 FDA UDI
- FDA Product Code
- JAQ FDA UDI
- EMDN Code
- Z11010380 BRACHYTHERAPY RADIATION SYSTEMS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Cervical/intrauterine 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
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: Cervical/intrauterine brachytherapy system applicator, manual
CT/MR Henschke Applicator Set, Varian by Mick Radio Nuclear Instrument, Inc — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED
Similar devices
Also classified as Cervical/intrauterine brachytherapy system applicator, manual.
- Intrauterine Tandem — LIBERTY MEDICAL INC · Class I
- Intrauterine Tandem — LIBERTY MEDICAL INC · Class I
- Cervical Applicator Set, Bundle 2 — Icad, Inc. · Class II
- Intrauterine Tandem — LIBERTY MEDICAL INC · Class I
- Intrauterine Tandem — LIBERTY MEDICAL INC · Class I
- Cervical Applicator Set, Bundle 1 — Icad, Inc. · Class II
- Intrauterine Tandem — LIBERTY MEDICAL INC · Class I
- Smit Sleeve 20mm — LIBERTY MEDICAL INC · Class I
Cleared under the same submission
K040704 also covers:
- CT Comp. Henschke GYN Appl, Titanium — MICK RADIO NUCLEAR INSTRUMENT, INC
- CT Comp. Split-Ring GYN Appl, Titanium — MICK RADIO NUCLEAR INSTRUMENT, INC
- CT/MR Cervical Stop for 3mm Tandems — MICK RADIO NUCLEAR INSTRUMENT, INC
- CT/MR Henschke Applicator Set, BEBIG — MICK RADIO NUCLEAR INSTRUMENT, INC
- CT/MR Henschke Applicator Set, Nucletron — MICK RADIO NUCLEAR INSTRUMENT, INC
- CT/MR Henschke Colpostat w Brack, Right, Nucletron — MICK RADIO NUCLEAR INSTRUMENT, INC
- CT/MR Henschke Colpostat w/ Brack, Left Nucletron — MICK RADIO NUCLEAR INSTRUMENT, INC
- CT/MR Henschke Left Colpostat w/ bracket, Varian — MICK RADIO NUCLEAR INSTRUMENT, INC
- CT/MR Henschke Max Curved Tandem, Nucletron — MICK RADIO NUCLEAR INSTRUMENT, INC
- CT/MR Henschke Maximum Curved IU Tube, Varian — MICK RADIO NUCLEAR INSTRUMENT, INC
- CT/MR Henschke Med Curve Tandem, Nucletron — MICK RADIO NUCLEAR INSTRUMENT, INC
- CT/MR Henschke Medium Curved IU Tube 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Mick Radio Nuclear Instrument, Inc
Sources (2)
- FDA UDI 01715f42-1e89-42ca-a4a8-067b3336ea4f 34 fields · synced Jul 10, 2026
- EUDAMED ab6812eb-ab10-4a6c-a069-3fb5df761957 61 fields · synced Jul 10, 2026