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AOS Interstitial Templates, Needles, and Accesories
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- AOS Interstitial Templates, Needles, and Accesories FDA UDI
- Generic Name
- Prostate brachytherapy system applicator, remote-afterloading FDA UDI
- Device Name
- Template, Syed/Neblett/Hedger, Series-17, Prostate, (18 Holes), Blue, 1 ea FDA UDI
- Model / Reference
- TPD0001-017 FDA UDI
- Description
- Template, Syed/Neblett/Hedger, Series-17, Prostate, (18 Holes), Blue, 1 ea FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850645007656 FDA UDI
- FDA Product Code
- JAQ FDA UDI
- GMDN Term
- Prostate 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
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Unsafe FDA UDI
Category: Prostate brachytherapy system applicator, remote-afterloading
AOS Interstitial Templates, Needles, and Accesories by Alpha-Omega Services, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Prostate brachytherapy system applicator, remote-afterloading.
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- Martinez Prostate Template — Nucletron B.V. · Class II
- Martinez Prostate Template — Nucletron B.V. · Class II
- Prostate Stepper Template — Nucletron B.V. · Class II
- Best Medical International — Best Medical International, Inc. · Class I
- Prostate Stepper Template — Nucletron B.V. · Class II
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
- Alpha-Omega Services, Inc.
Sources (1)
- FDA UDI 95d536ad-6faf-4cb6-adaa-af0826c3c94e 33 fields · synced Jun 8, 2026