Identity
- Trade Name
- EP1-3G & CAT-2 FDA UDI
- Generic Name
- Medical device cleaning sponge/set FDA UDI
- Device Name
- EP1-3G & CAT-2 - 50 Each FDA UDI
- Model / Reference
- EP90-3G FDA UDI
- Description
- EP1-3G & CAT-2 - 50 Each FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00843356100334 FDA UDI
- FDA Product Code
- MNL FDA UDI
- GMDN Term
- Medical device cleaning sponge/set FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 876.1500 FDA UDI
- Commercial Distribution
- Not 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
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Ep1-3g & Cat-2 by Cygnus Medical L.l.c. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Cygnus Medical L.l.c.
Sources (1)
- FDA UDI 2e80a246-d5bf-4b3f-996e-e37aa33a993b 34 fields · synced May 30, 2026