Identity
- Trade Name
- Endo Direct Sodium hypoclorite 6% FDA UDI
- Generic Name
- Root canal cleaning solution FDA UDI
- Model / Reference
- EDSH480ML6 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10810138822675 FDA UDI
- FDA Product Code
- KJJ FDA UDI
- GMDN Term
- Root canal cleaning solution FDA UDI
Classification
- Device Class
- U 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
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: Root canal cleaning solution
Endo Direct Sodium hypoclorite 6% by Endo Direct, Llc — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Root canal cleaning solution.
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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 U | Pending data |
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Manufacturer
- Manufacturer
- Endo Direct, Llc
Sources (1)
- FDA UDI 050390fd-864a-4a22-8d7b-85de88a2cd6f 33 fields · synced May 30, 2026