Identity
- Trade Name
- BodyMed FDA UDI
- Generic Name
- Transcutaneous electrical stimulation electrode, single-use FDA UDI
- Device Name
- BODYMED 3" X 5" RECTANGULAR CLOTH BACK CARBON ELECTRODE, LATEX FREE, 2/PACK FDA UDI
- Model / Reference
- NPP609 FDA UDI
- Description
- BODYMED 3" X 5" RECTANGULAR CLOTH BACK CARBON ELECTRODE, LATEX FREE, 2/PACK FDA UDI
Identifiers
- Catalog Number
- NPP609 FDA UDI
- Primary DI / UDI-DI
- 00815802010290 FDA UDI
- FDA Product Code
- GXY FDA UDI
- GMDN Term
- Transcutaneous electrical stimulation electrode, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.1320 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
Yes
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: Transcutaneous electrical stimulation electrode, single-use
BodyMed by Boxout, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K092546 also covers:
K160138 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
- Boxout, Llc
Sources (1)
- FDA UDI eaafe895-8fcc-48b6-81bb-e68bad9eecec 36 fields · synced May 29, 2026