Identity
- Trade Name
- EVONOS FDA UDI
- Generic Name
- Middle ear pick FDA UDI
- Device Name
- RONIS 45 DEGREE ANGLE PICK, LARGE FDA UDI
- Model / Reference
- 130363 FDA UDI
- Description
- RONIS 45 DEGREE ANGLE PICK, LARGE FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00821925013803 FDA UDI
- FDA Product Code
- LRC 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
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Middle ear pick
Evonos by Gyrus Acmi, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Middle ear pick.
- BOSS Instruments — Boss Instruments, Ltd. · Class I
- FENTEX — FENTEX medical GmbH · Class I
- Avalign — AVALIGN TECHNOLOGIES, Inc. · Class I
- Integra® — Integra LifeSciences Production Corporation · Class I
- FENTEX — FENTEX medical GmbH · Class I
- SCHWERT — A. Schweickhardt GmbH & Co. KG · Class I
- Millennium — AVALIGN TECHNOLOGIES, Inc. · Class I
- Novo Surgical — NOVO 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Gyrus Acmi, Inc.
Sources (1)
- FDA UDI 0a062b0c-c87b-490b-9544-ceab310e70a9 33 fields · synced Jun 1, 2026