Identity
- Trade Name
- Avalign FDA UDI
- Generic Name
- Rigid optical nasopharyngoscope FDA UDI
- Device Name
- Sinuscope, angled autoclavable, 30ø, wide, Diameter 4mm, WL 185mm (7 3/8") FDA UDI
- Model / Reference
- VM104-6916 FDA UDI
- Description
- Sinuscope, angled autoclavable, 30ø, wide, Diameter 4mm, WL 185mm (7 3/8") FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00190776126575 FDA UDI
- FDA Product Code
- EOB FDA UDI
- GMDN Term
- Rigid optical nasopharyngoscope FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 874.4760 FDA UDI
- Commercial Distribution
- 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
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
Category: Rigid optical nasopharyngoscope
Avalign by AVALIGN TECHNOLOGIES, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Rigid optical nasopharyngoscope.
- RIGID SCOPES — PENTAX of America, Inc. · Class I
- RIGID SCOPES — PENTAX of America, Inc. · Class I
- ACCLARENT CYCLOPS — ACCLARENT, INC. · Class II
- Sharpsite® — MEDTRONIC XOMED, INC. · Class II
- Sharpsite® — MEDTRONIC XOMED, INC. · Class II
- SHARPSITE® — MEDTRONIC XOMED, INC. · Class II
- Sharpsite® — MEDTRONIC XOMED, INC. · Class II
- SINUSCOPE — PENTAX of America, Inc. · 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
- AVALIGN TECHNOLOGIES, Inc.
Sources (1)
- FDA UDI 3d6db6e1-cd3a-4f52-9927-9f58585a38d7 34 fields · synced May 30, 2026