Identity
- Trade Name
- JustRight Sealer FDA UDI
- Generic Name
- Endoscopic electrosurgical handpiece/electrode, bipolar, single-use FDA UDI
- Device Name
- JustRight Sealer - single FDA UDI
- Model / Reference
- JR-SE20 FDA UDI
- Description
- JustRight Sealer - single FDA UDI
Identifiers
- Catalog Number
- JR-SE20 FDA UDI
- Primary DI / UDI-DI
- 00865163000126 FDA UDI
- 510(k) Number
- K123662 FDA UDI
- FDA Product Code
- GEI FDA UDI
- GMDN Term
- Endoscopic electrosurgical handpiece/electrode, bipolar, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4400 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Ethylene Oxide FDA UDI
Category: Endoscopic electrosurgical handpiece/electrode, bipolar, single-use
JustRight Sealer by Justright Surgical — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K123662 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
- Justright Surgical
Sources (1)
- FDA UDI 6d165e78-f06d-4e62-9557-8c8ea9fcde1b 37 fields · synced May 30, 2026