Identity
- Trade Name
- Avalign FDA UDI
- Generic Name
- Spinal rongeur FDA UDI
- Device Name
- Micro Kerrison, flush FDA UDI
- Model / Reference
- NL4281-72 FDA UDI
- Description
- Micro Kerrison, flush FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00190776001247 FDA UDI
- FDA Product Code
- HAE FDA UDI
- GMDN Term
- Spinal rongeur FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.4840 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
Dimensions & Sizes
- Size
- Width — 2 Millimeter FDA UDILength — 7 Inch FDA UDIAngle — 40 degree FDA UDI
Category: Spinal rongeur
Avalign by AVALIGN TECHNOLOGIES, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Spinal rongeur.
- Sklar — Sklar Corporation · Class I
- Medicon — Medicon eG. Chirurgiemechaniker-Genossenschaft · Class I
- V. Mueller — STERIS CORPORATION · Class II
- Boss Instruments — Boss Instruments, Ltd. · Class II
- SURGIPROS — SURGIPROS LLC · Class I
- Boss Instruments — Boss Instruments, Ltd. · Class II
- Surgical Direct — SURGICAL DIRECT, INC. · Class I
- MIASPAS MINI-ALIF — AESCULAP, 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 II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- AVALIGN TECHNOLOGIES, Inc.
Sources (1)
- FDA UDI 689c3de6-2b4d-49d5-90a7-70729fd9caf3 35 fields · synced May 30, 2026