Identity
- Trade Name
- PDI® Electrode Prep Pad FDA UDI
- Generic Name
- Skin degreaser FDA UDI
- Device Name
- Pre-moistened pad used to remove surface skin oil and cleanse skin area in preparation for electrode placement. FDA UDI
- Model / Reference
- B59800 FDA UDI
- Description
- Pre-moistened pad used to remove surface skin oil and cleanse skin area in preparation for electrode placement. FDA UDI
Identifiers
- Catalog Number
- B59800 FDA UDI
- Primary DI / UDI-DI
- 00310819000475 FDA UDI
- FDA Product Code
- KOY FDA UDI
- GMDN Term
- Skin degreaser FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4730 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
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Width — 1.2 Inch FDA UDILength — 2.6 Inch FDA UDI
PDI® Electrode Prep Pad by Professional Disposables International, Inc. — 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Professional Disposables International, Inc.
Sources (1)
- FDA UDI 92d58e34-9441-429a-831b-26ed858b63d4 37 fields · synced Jun 8, 2026