Identity
- Trade Name
- Grafco FDA UDI
- Generic Name
- Transcutaneous electrical stimulation electrode, single-use FDA UDI
- Device Name
- TENS Electrodes FDA UDI
- Model / Reference
- 9261 FDA UDI
- Description
- TENS Electrodes FDA UDI
Identifiers
- Primary DI / UDI-DI
- M36892611 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
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: Transcutaneous electrical stimulation electrode, single-use
Grafco by GF Health Products, Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Transcutaneous electrical stimulation electrode, single-use.
- AUVON — Shenzhen Yuwen E-Commerce Co., Ltd. · Class II
- Eswallow — COMPASS HEALTH BRANDS CORP. · Class II
- TMR-ELEC-20003221 2" WH Round electrode — Emsi · Class II
- Medical Science Products — SAUVRE INTERNATIONAL, LTD. · Class II
- AdvanTrode — PEPIN MANUFACTURING, INC. · Class II
- 3x5 fabric conductive pad — BioMedical Life Systems Inc. · Class II
- MediMax Tech — MEDIMAX TECH INC. · Class II
- ProPatch — PRO MEDICAL SUPPLIES, INC. · Class II
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
- GF Health Products, Inc
Sources (1)
- FDA UDI 2946fa1b-7881-4038-8da4-8ee6ebd6c431 35 fields · synced May 30, 2026