Identity
- Trade Name
- Avalign FDA UDI
- Generic Name
- Middle ear malleus nipper FDA UDI
- Device Name
- Tissue Nipper FDA UDI
- Model / Reference
- VM89-2059 FDA UDI
- Description
- Tissue Nipper FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00190776069445 FDA UDI
- FDA Product Code
- FZT FDA UDI
- GMDN Term
- Middle ear malleus nipper FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 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 malleus nipper
Avalign by AVALIGN TECHNOLOGIES, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Middle ear malleus nipper.
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- Dieter malleus nipper — Spiggle & Theis Medizintechnik GmbH · Class I
- Dieter malleus nipper — Spiggle & Theis Medizintechnik 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 c5b72616-e733-42c7-ac35-4a92383935ca 34 fields · synced Jun 1, 2026