Identity
- Trade Name
- Curaplex FDA UDI
- Generic Name
- Electrode conductive skin pad, single-use FDA UDI
- Device Name
- Curaplex Select Defibrillation Electrode, Cardiac Science , Adult 10pr/CASE FDA UDI
- Model / Reference
- T100-CASE FDA UDI
- Description
- Curaplex Select Defibrillation Electrode, Cardiac Science , Adult 10pr/CASE FDA UDI
Identifiers
- Catalog Number
- 16382 FDA UDI
- Primary DI / UDI-DI
- 00817617029634 FDA UDI
- FDA Product Code
- MKJ FDA UDI
- GMDN Term
- Electrode conductive skin pad, single-use FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Regulation Number
- 870.5310 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Electrode conductive skin pad, single-use
Curaplex by Bound Tree Medical, Llc — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Electrode conductive skin pad, single-use.
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- Defibrillation Electrodes — Tz Medical, Inc. · Class II
- Medline — MEDLINE INDUSTRIES, INC. · Class II
- Defibrillation Electrodes — Tz Medical, Inc. · Class II
- Defibrillation Electrodes — Tz Medical, Inc. · Class II
- Adult/Child, radiotransparent, defib electrodes with increased adhesive surface — HEART SYNC 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 III | Pending data |
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Manufacturer
- Manufacturer
- Bound Tree Medical, Llc
Sources (1)
- FDA UDI f0a71865-6ec7-446b-b8ad-d2637aaea049 35 fields · synced May 30, 2026