Identity
- Trade Name
- Howard Leight FDA UDI
- Generic Name
- Earplugs, single-use FDA UDI
- Device Name
- FirmFit Uncorded Earplug Refill for Leight Source 400 Dispenser, 200 Pairs FDA UDI
- Model / Reference
- FIRMFIT FDA UDI
- Description
- FirmFit Uncorded Earplug Refill for Leight Source 400 Dispenser, 200 Pairs FDA UDI
Identifiers
- Catalog Number
- FF-LS4 FDA UDI
- Primary DI / UDI-DI
- 00033552021124 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
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: Earplugs, single-use
Howard Leight by Sperian Hearing Protection, Llc — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 715ce33b-be01-4e0c-9cae-f925f06fb81f 34 fields · synced Jun 6, 2026