Identity
- Trade Name
- 3M™ FDA UDI
- Generic Name
- Electrosurgical return electrode, single-use FDA UDI
- Device Name
- 3M™ Electrosurgical Pad, Split, Large, Non-Corded 8180F FDA UDI
- Model / Reference
- 8180F FDA UDI
- Description
- 3M™ Electrosurgical Pad, Split, Large, Non-Corded 8180F FDA UDI
Identifiers
- Catalog Number
- 8180F FDA UDI
- Primary DI / UDI-DI
- 50707387563504 FDA UDI
- 510(k) Number
- K833364 FDA UDI
- FDA Product Code
- GEI FDA UDI
- GMDN Term
- Electrosurgical return electrode, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4400 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
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Electrosurgical return electrode, single-use
3m™ by 3m Company — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K833364 also covers:
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 II | Pending data |
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Manufacturer
- Manufacturer
- 3m Company
Sources (1)
- FDA UDI f7b9041e-35b8-4335-afa1-956eeb514bab 36 fields · synced Jun 1, 2026