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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
- General-purpose brachytherapy system applicator, remote-afterloading FDA UDI
- Device Name
- Needle, Template Stainless Steel with Threaded Female Hub and Stylet with 90 degree bend, Series-17, 20 cm, 10 ea FDA UDI
- Model / Reference
- NHD0001-002 FDA UDI
- Description
- Needle, Template Stainless Steel with Threaded Female Hub and Stylet with 90 degree bend, Series-17, 20 cm, 10 ea FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850645007588 FDA UDI
- 510(k) Number
- K233628 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
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: General-purpose 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 General-purpose brachytherapy system applicator, remote-afterloading.
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- Best Medical International — Best Medical International, Inc. · Class I
- Best Medical International — Best Medical International, Inc. · Class I
Cleared under the same submission
K233628 also covers:
- AOS Interstitial Templates, Needles, and Accesories — ALPHA-OMEGA SERVICES, INC.
- AOS Interstitial Templates, Needles, and Accesories — ALPHA-OMEGA SERVICES, INC.
- AOS Interstitial Templates, Needles, and Accesories — ALPHA-OMEGA SERVICES, INC.
- AOS Interstitial Templates, Needles, and Accessories — ALPHA-OMEGA SERVICES, 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
- Alpha-Omega Services, Inc.
Sources (1)
- FDA UDI 511ec9ed-41c2-4927-a8b5-241891bfed6a 34 fields · synced Jun 8, 2026