Identity
- Trade Name
- Howard Leight by Honeywell FDA UDI
- Generic Name
- Earplugs, single-use FDA UDI
- Device Name
- AquaSeal Water-Blocking Reusable Earplugs with Carrying Case, 2-Pairs Howard Leight by Honeywell AquaSeal Water-Blocking Reusable Earplugs are specially designed to help prevent swimmer's ear. Using a triple flange design, these earplugs create a series of low-pressure air pocket seals inside your ear canal. The result is a comfortable, water-resistant earplug that's soft on your inner ear. Insertion and removal are easy thanks to the convenient outer handle. This package comes with a convenient carrying case for easy storage in the boat, on the dock, or in your pocket. 2 pairs of earplugs per pack FDA UDI
- Model / Reference
- AquaSeal FDA UDI
- Description
- AquaSeal Water-Blocking Reusable Earplugs with Carrying Case, 2-Pairs Howard Leight by Honeywell AquaSeal Water-Blocking Reusable Earplugs are specially designed to help prevent swimmer's ear. Using a triple flange design, these earplugs create a series of low-pressure air pocket seals inside your ear canal. The result is a comfortable, water-resistant earplug that's soft on your inner ear. Insertion and removal are easy thanks to the convenient outer handle. This package comes with a convenient carrying case for easy storage in the boat, on the dock, or in your pocket. 2 pairs of earplugs per pack FDA UDI
Identifiers
- Catalog Number
- R-01684 FDA UDI
- Primary DI / UDI-DI
- 00033552016847 FDA UDI
- FDA Product Code
- EWD FDA UDI
- GMDN Term
- Earplugs, single-use FDA UDI
Classification
- Device Class
- U 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
No
FDA UDI
Over-the-Counter
Yes
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: Earplugs, single-use
Howard Leight by Honeywell by Sperian Hearing Protection, Llc — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Earplugs, single-use.
- Top Care — Topco Associates, LLC · U
- Acu-Life (HE) — Apothecary Products, Inc. · U
- BIOS Living — Thermor Ltd · U
- Flents — Apothecary Products, Inc. · U
- FLENTS PROTECHS — Apothecary Products, Inc. · U
- Acu-Life (HE) — Apothecary Products, Inc. · U
- Meniett™ Earplug, Clear, 19 mm — Lina Medical ApS · Class II
- ULINE EARPLUGS IN A BUCKET — ULINE, INC. · U
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 U | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Sperian Hearing Protection, Llc
Sources (1)
- FDA UDI 61886c91-8bb4-40da-95fe-35dd11eb0fe1 34 fields · synced Jun 8, 2026