Identity
- Trade Name
- CoolSeal Trinity 44CM EUDAMEDCoolSeal™ Trinity FDA UDI
- Generic Name
- Endoscopic electrosurgical handpiece/electrode, bipolar, single-use FDA UDI
- Device Name
- CoolSeal Trinity EUDAMEDMaryland Laparoscopic Sealer/Divider/Dissector, 44 cm FDA UDI
- Model / Reference
- CSL-TR105-44 EUDAMEDFDA UDI
- Description
- Maryland Laparoscopic Sealer/Divider/Dissector, 44 cm FDA UDI
Identifiers
- Catalog Number
- CSL-TR105-44 FDA UDI
- Primary DI / UDI-DI
- 00850346007061 EUDAMEDFDA UDI
- Basic UDI-DI
- 0850346007GSSCSL-TRDX EUDAMED
- Direct Marketing DI
- 00850346007061 EUDAMED
- FDA Product Code
- GEI FDA UDI
- EMDN Code
- Z12010985 ELECTROSURGERY INSTRUMENTS - CONSUMABLES EUDAMED
- GMDN Term
- Endoscopic electrosurgical handpiece/electrode, bipolar, single-use FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4400 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
Dimensions & Sizes
- Size
- Length — 44 Centimeter FDA UDI
Category: Endoscopic electrosurgical handpiece/electrode, bipolar, single-use
CoolSeal™ Trinity by Justright Surgical — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Justright Surgical
Sources (2)
- FDA UDI 28fc9694-d037-4ccb-9ce3-eb4ab79ec485 37 fields · synced Jul 17, 2026
- EUDAMED c3411581-303f-47f9-b3ef-da32e3c5eb13 61 fields · synced Jul 17, 2026