Identity
- Trade Name
- Leader FDA UDI
- Generic Name
- Earplugs, single-use FDA UDI
- Device Name
- Ultra-Soft Silicone Earplugs 6 Pairs FDA UDI
- Model / Reference
- 41344 FDA UDI
- Description
- Ultra-Soft Silicone Earplugs 6 Pairs FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00096295138634 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
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Earplugs, single-use
Leader by Cirrus Healthcare Products 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
- Cirrus Healthcare Products Llc
Sources (1)
- FDA UDI ea113338-0084-4fb5-9c1f-ea87c8373ce1 33 fields · synced May 30, 2026