Identity
- Trade Name
- Meniett FDA UDI
- Generic Name
- Earplugs, single-use FDA UDI
- Device Name
- GENERATOR 1010020401LO LOANER MENIETT US FDA UDI
- Model / Reference
- 1010020401LO FDA UDI
- Description
- GENERATOR 1010020401LO LOANER MENIETT US FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00721902541094 FDA UDI
- 510(k) Number
- K991562 FDA UDI
- FDA Product Code
- ETY FDA UDI
- GMDN Term
- Earplugs, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 874.1090 FDA UDI
- Commercial Distribution
- Not 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Meniett by Medtronic Xomed, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K991562 also covers:
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
- Medtronic Xomed, Inc.
Sources (1)
- FDA UDI ebb74153-45d1-47f4-9600-aa679c27eed4 36 fields · synced Jun 1, 2026