Identity
- Trade Name
- AOS Flexiguide Needle FDA UDI
- Generic Name
- General-purpose brachytherapy system applicator, remote-afterloading FDA UDI
- Device Name
- Needle, Flexiguide with Female Luer Adaptor and Stylet with Male Luer Adaptor, Series-15, 20 cm, 10 ea FDA UDI
- Model / Reference
- NFV0003-003 FDA UDI
- Description
- Needle, Flexiguide with Female Luer Adaptor and Stylet with Male Luer Adaptor, Series-15, 20 cm, 10 ea FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850645007342 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
Yes
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Ethylene Oxide FDA UDI
AOS Flexiguide Needle by Alpha-Omega Services, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 3347033f-bb9d-46cb-bd55-26bd6d136669 34 fields · synced Jun 8, 2026