Identity
- Trade Name
- Avalign FDA UDI
- Generic Name
- Ear knife FDA UDI
- Device Name
- Paparella Incudostapedial Knife, #4, FDA UDI
- Model / Reference
- VM101-4617 FDA UDI
- Description
- Paparella Incudostapedial Knife, #4, FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00190776044428 FDA UDI
- FDA Product Code
- KTG FDA UDI
- GMDN Term
- Ear knife 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: Ear knife
Avalign by AVALIGN TECHNOLOGIES, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Ear knife.
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- BOSS Instruments — Boss Instruments, Ltd. · Class I
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- BOSS Instruments — Boss Instruments, Ltd. · Class I
- HNM MEDICAL — HNM STAINLESS, LLC. · Class I
- Fisch sickle knife — Spiggle & Theis Medizintechnik GmbH · Class I
- FENTEX — FENTEX medical GmbH · 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 a23a3d49-d360-4683-9805-ada8bc50b607 34 fields · synced Jun 6, 2026