Identity
- Trade Name
- Eye Pads - 10/Box FDA UDI
- Generic Name
- Eye pad FDA UDI
- Device Name
- Eye Pads - 10/Box FDA UDI
- Model / Reference
- R231-115 FDA UDI
- Description
- Eye Pads - 10/Box FDA UDI
Identifiers
- Catalog Number
- R231-115 FDA UDI
- Primary DI / UDI-DI
- 00766588311159 FDA UDI
- 510(k) Number
- K940333 FDA UDI
- FDA Product Code
- HMP FDA UDI
- GMDN Term
- Eye pad FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4440 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Eye pad
Eye Pads - 10/Box by Certified Safety Manufacturing, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Bioseal Inc. — BIOSEAL · Class I
Cleared under the same submission
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 |
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Manufacturer
- Manufacturer
- Certified Safety Manufacturing, Inc.
Sources (1)
- FDA UDI e0ec51b0-5ff4-488f-943d-caad5c101db8 36 fields · synced May 30, 2026