Identity
- Trade Name
- Henschke Ovoids With Tungsten Segments & Caps Set FDA UDI
- Generic Name
- Cervical/intrauterine brachytherapy system applicator, manual FDA UDI
- Model / Reference
- 6402-05 FDA UDI
Identifiers
- Catalog Number
- 6402-05 FDA UDI
- Primary DI / UDI-DI
- 00817330020000 FDA UDI
- 510(k) Number
- K040704 FDA UDI
- FDA Product Code
- JAQ FDA UDI
- GMDN Term
- Cervical/intrauterine 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
Yes
FDA UDI
Serial Number
No
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
Henschke Ovoids With Tungsten Segments & Caps Set by Mick Radio Nuclear Instrument, Inc — Class II — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as Cervical/intrauterine brachytherapy system applicator, manual.
- Intrauterine Tandem — LIBERTY MEDICAL INC · Class I
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- 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 Applicator Set, Varian — 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
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 730e89bc-bc45-4f88-af77-0531a79200bb 34 fields · synced Jun 6, 2026