Identity
- Trade Name
- H.A.M. Sizing Template, 02cm FDA UDI
- Generic Name
- General-purpose brachytherapy system applicator, manual FDA UDI
- Model / Reference
- 0408-04-02 FDA UDI
Identifiers
- Catalog Number
- 0408-04-02 FDA UDI
- Primary DI / UDI-DI
- 00817330020628 FDA UDI
- 510(k) Number
- K961601 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
Yes
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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: General-purpose brachytherapy system applicator, manual
H.A.M. Sizing Template, 02cm by Mick Radio Nuclear Instrument, Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as General-purpose brachytherapy system applicator, manual.
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Cleared under the same submission
K961601 also covers:
- H.A.M. Breast Applicator, 06-Channel — MICK RADIO NUCLEAR INSTRUMENT, INC
- H.A.M. Breast Applicator, 07-Channel — MICK RADIO NUCLEAR INSTRUMENT, INC
- H.A.M. Shielded Breast Appl Set, 04-Chan — MICK RADIO NUCLEAR INSTRUMENT, INC
- H.A.M. Shielded Breast Appl Set, 10-Chan — MICK RADIO NUCLEAR INSTRUMENT, INC
- H.A.M. Sizing Template, 04cm — MICK RADIO NUCLEAR INSTRUMENT, INC
- H.A.M. Sizing Template, 06cm — MICK RADIO NUCLEAR INSTRUMENT, INC
- H.A.M. Sizing Template, 10cm — MICK RADIO NUCLEAR INSTRUMENT, INC
- H.A.M. Tungsten Shield for 05-Channel Appl — MICK RADIO NUCLEAR INSTRUMENT, INC
- H.A.M. Tungsten Shield for 06-Channel Appl — MICK RADIO NUCLEAR INSTRUMENT, INC
- H.A.M. Tungsten Shield for 08-Channel Appl — MICK RADIO NUCLEAR INSTRUMENT, INC
- H.A.M., 03-Chan, 100cm catheters, Slot , Varisource — MICK RADIO NUCLEAR INSTRUMENT, INC
- H.A.M., 03-Chan, 130cm cath, Slot, Varian-Gammamed — 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 25ea114e-9af5-49d8-a246-0a098e9aa958 34 fields · synced Jun 8, 2026