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Double plane templates, 14 mm hole separation, 6 holes across bottom width
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- Double plane templates, 14 mm hole separation, 6 holes across bottom width FDA UDI
- Generic Name
- General-purpose brachytherapy system applicator, remote-afterloading FDA UDI
- Model / Reference
- AL07349008 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00816389020603 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
- Not 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
Double plane templates, 14 mm hole separation, 6 holes across bottom width by Varian Medical Systems Deutschland GmbH — Class II — FDA UDI — listed in FDA GUDID
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 Allen tool — 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 aeb23339-48d1-4ba2-89a6-9cf500727eec 34 fields · synced Jun 1, 2026