Identity
- Trade Name
- Avalign FDA UDI
- Generic Name
- Middle ear pick FDA UDI
- Device Name
- Perforating Needle, FDA UDI
- Model / Reference
- VM101-4546 FDA UDI
- Description
- Perforating Needle, FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00190776044411 FDA UDI
- FDA Product Code
- KBR FDA UDI
- GMDN Term
- Middle ear pick FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 874.4420 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
Yes
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: Middle ear pick
Avalign by AVALIGN TECHNOLOGIES, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Middle ear pick.
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- FENTEX — FENTEX medical GmbH · Class I
- Integra® — Integra LifeSciences Production Corporation · Class I
- FENTEX — FENTEX medical GmbH · Class I
- SCHWERT — A. Schweickhardt GmbH & Co. KG · Class I
- Novo Surgical — NOVO SURGICAL, INC. · Class I
- Medicon — Medicon eG. Chirurgiemechaniker-Genossenschaft · Class I
- Symmetry Austin — SYMMETRY SURGICAL INC. · Class I
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 I | Pending data |
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Manufacturer
- Manufacturer
- AVALIGN TECHNOLOGIES, Inc.
Sources (1)
- FDA UDI 1b0f90f5-6c80-4e9e-aa0e-b95562d654b2 34 fields · synced May 30, 2026