Identity
- Trade Name
- Needle securing Allen tool FDA UDI
- Generic Name
- General-purpose brachytherapy system applicator, remote-afterloading FDA UDI
- Model / Reference
- AL07346000 FDA UDI
Identifiers
- Catalog Number
- AL07346000 FDA UDI
- Primary DI / UDI-DI
- 00816389020498 FDA UDI
- 510(k) Number
- K023220 FDA UDI
- FDA Product Code
- JAQ FDA UDI
- GMDN Term
- General-purpose brachytherapy system applicator, remote-afterloading 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
No
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
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: General-purpose brachytherapy system applicator, remote-afterloading
Needle securing Allen tool by Varian Medical Systems Deutschland GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K023220 also covers:
- Breast Bridge — Varian Medical Systems Deutschland GmbH
- Double plane templates, 10 mm hole separation, 8 holes across width — Varian Medical Systems Deutschland GmbH
- Double plane templates, 16 mm hole separation, 5 holes across bottom width — Varian Medical Systems Deutschland GmbH
- Needle pusher — Varian Medical Systems Deutschland GmbH
- Needle securing collets for fixation of needles to templates, set of 10 — Varian Medical Systems Deutschland GmbH
- Single plane templates, 10 mm hole separation, 8 holes across width — Varian Medical Systems Deutschland GmbH
- Single plane templates, 16 mm hole separation, 5 holes across width — Varian Medical Systems Deutschland GmbH
- Triple plane templates, 10 mm hole separation, 8 holes across bottom width — Varian Medical Systems Deutschland GmbH
- Triple plane templates, 16 mm hole separation, 5 holes across bottom width — Varian Medical Systems Deutschland GmbH
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
- Varian Medical Systems Deutschland GmbH
Sources (1)
- FDA UDI 4cc1ad2e-6c77-4617-90f2-5e4f6760bf9d 34 fields · synced Jun 8, 2026