Identity
- Trade Name
- GIBSON HEALTHCARE FDA UDI
- Generic Name
- Root canal cleaning solution FDA UDI
- Device Name
- Gibson Healthcare Endo Irrigation Single Canal Kit. Contains: (1) 10ml pre-filled sodium hypochlorite syringe, (1) 3ml pre-filled EDTA syringe, (1) 3ml pre-filled 95% ethyl alcohol syringe, (1) 3ml pre-filled chlorhexidine syringe, (4) 30g irrigation needle tips, (1) canal aspiratior with tip. FDA UDI
- Model / Reference
- 5126-301 FDA UDI
- Description
- Gibson Healthcare Endo Irrigation Single Canal Kit. Contains: (1) 10ml pre-filled sodium hypochlorite syringe, (1) 3ml pre-filled EDTA syringe, (1) 3ml pre-filled 95% ethyl alcohol syringe, (1) 3ml pre-filled chlorhexidine syringe, (4) 30g irrigation needle tips, (1) canal aspiratior with tip. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00366975032812 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
Yes
FDA UDI
Combination Product
Yes
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
Gibson Healthcare by Benco Dental Supply Co. — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Benco Dental Supply Co.
Sources (1)
- FDA UDI 68253ab5-6c40-4390-b414-816d798aec3a 34 fields · synced Jun 8, 2026