Identity
- Trade Name
- Howard Leight FDA UDI
- Generic Name
- Acoustic earmuffs FDA UDI
- Device Name
- Impact Pro High NRR Sound Amplification Electronic Earmuff, Black & Gray FDA UDI
- Model / Reference
- Impact Pro FDA UDI
- Description
- Impact Pro High NRR Sound Amplification Electronic Earmuff, Black & Gray FDA UDI
Identifiers
- Catalog Number
- R-01902 FDA UDI
- Primary DI / UDI-DI
- 00033552019022 FDA UDI
- FDA Product Code
- EWE FDA UDI
- GMDN Term
- Acoustic earmuffs FDA UDI
Classification
- Device Class
- U 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
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: Acoustic earmuffs
Howard Leight by Sperian Hearing Protection, Llc — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Acoustic earmuffs.
- Condor — GRAINGER INTERNATIONAL, INC. · U
- MiniMuffs — Canadian Hospital Specialties Limited · U
- Condor — GRAINGER INTERNATIONAL, INC. · U
- Bio-logic — Natus Medical Incorporated · Class II
- Howard Leight — SPERIAN HEARING PROTECTION, LLC · U
- Howard Leight — SPERIAN HEARING PROTECTION, LLC · U
- Howard Leight — SPERIAN HEARING PROTECTION, LLC · U
- Howard Leight — SPERIAN HEARING PROTECTION, LLC · 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 |
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Manufacturer
- Manufacturer
- Sperian Hearing Protection, Llc
Sources (1)
- FDA UDI 628c9b54-88c8-4b78-89d3-4107919d401f 35 fields · synced May 30, 2026