Identity
- Trade Name
- LightBeam FDA UDI
- Generic Name
- Endaural wax extraction curette FDA UDI
- Device Name
- 50 Pieces of Lighted Tamper Curette FDA UDI
- Model / Reference
- LB10-refill FDA UDI
- Description
- 50 Pieces of Lighted Tamper Curette FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810323000003 FDA UDI
- FDA Product Code
- JYG FDA UDI
- GMDN Term
- Endaural wax extraction curette 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
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Endaural wax extraction curetteENT illuminating foreign body extraction set
LightBeam by Ear Technology Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as ENT illuminating foreign body extraction set.
- McKesson — MCKESSON MEDICAL-SURGICAL INC. · Class I
- McKesson — MCKESSON MEDICAL-SURGICAL INC. · Class I
- McKesson — MCKESSON MEDICAL-SURGICAL INC. · Class I
- McKesson — MCKESSON MEDICAL-SURGICAL INC. · Class I
- ClearLook Lighted Variety Pack with Rechargeable Light Source — Bionix, LLC · Class I
- ClearLook™ Sample Pack-Curettes Only — Bionix, LLC · Class I
- McKesson — MCKESSON MEDICAL-SURGICAL INC. · Class I
- ClearLook Lighted MicroLoop, Refill — Bionix, LLC · 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
- Ear Technology Corporation
Sources (1)
- FDA UDI 7257968f-2c6d-4bd6-8c81-94d5d92d6f40 34 fields · synced Jun 9, 2026