Identity
- Trade Name
- Grounding Pads FDA UDI
- Generic Name
- Electrosurgical return electrode, single-use FDA UDI
- Device Name
- A grounding pad is placed on the body (usually the thigh) before the surgery to protect the person from the harmful effects of the electricity. FDA UDI
- Model / Reference
- 1 FDA UDI
- Description
- A grounding pad is placed on the body (usually the thigh) before the surgery to protect the person from the harmful effects of the electricity. FDA UDI
Identifiers
- Catalog Number
- DU2100 FDA UDI
- Primary DI / UDI-DI
- 00850014433161 FDA UDI
- 510(k) Number
- K102372 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
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Electrosurgical return electrode, single-use
Grounding Pads by Distribution Unlimited, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Electrosurgical return electrode, single-use.
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Cleared under the same submission
K102372 also covers:
- RF Disposable Grounding Pad — Celling Biosciences
- Halyard — OWENS & MINOR DISTRIBUTION, INC.
- Halyard — OWENS & MINOR DISTRIBUTION, INC.
- Halyard — OWENS & MINOR DISTRIBUTION, INC.
- 20230 Electrosurgical Grounding Pad without Cord — XODUS MEDICAL, INC.
- 20240 Electrosurgical Grounding Pad with Cord — XODUS MEDICAL, INC.
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Distribution Unlimited, Llc
Sources (1)
- FDA UDI e9619947-ee00-4818-ab7d-570a3fa77c9d 35 fields · synced May 31, 2026