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AOS Interstitial Templates, Needles, and Accessories
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- AOS Interstitial Templates, Needles, and Accessories FDA UDI
- Generic Name
- Vaginal brachytherapy system applicator, remote-afterloading FDA UDI
- Device Name
- Guide, Vaginal, Series-17, 12 cm, with Blue set screw, 1 ea FDA UDI
- Model / Reference
- GVN1517-005 FDA UDI
- Description
- Guide, Vaginal, Series-17, 12 cm, with Blue set screw, 1 ea FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850645007304 FDA UDI
- 510(k) Number
- K233628 FDA UDI
- FDA Product Code
- JAQ FDA UDI
- GMDN Term
- Vaginal 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: Vaginal brachytherapy system applicator, remote-afterloading
AOS Interstitial Templates, Needles, and Accessories by Alpha-Omega Services, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Vaginal brachytherapy system applicator, remote-afterloading.
- Smit cervical sleeve 40 mm, with clamping for guiding tube — Varian Medical Systems Deutschland GmbH · Class II
- Applicator probe, 6.3 mm diameter x 320 mm, curved 30 degrees, 70 mm — Varian Medical Systems Deutschland GmbH · Class II
- Source guide tube with locking mechanism, third party applicator — Varian Medical Systems, Inc · Class II
- Front segment open 35 mm diameter, straight, length 60 mm — Varian Medical Systems Deutschland GmbH · Class II
- Applicator probe 3mm diameter x 320 mm, straight — Varian Medical Systems Deutschland GmbH · Class II
- Surface cone inset, ø20 mm, round — Varian Medical Systems Deutschland GmbH · Class II
- 5 cm intrauterine probe angled 20 degrees, for 3-channel applicator — Varian Medical Systems Deutschland GmbH · Class II
- Applicator probe, 6.3 mm diameter x 320 mm, curved 15 degrees, 60 mm — Varian Medical Systems Deutschland GmbH · Class II
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 Accesories — 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 5095933e-5f32-4918-bd97-18edd8c17418 34 fields · synced Jun 8, 2026