Identity
- Trade Name
- CoolSeal Generator EUDAMEDCoolSeal™ Generator FDA UDI
- Generic Name
- Electrosurgical system generator FDA UDI
- Device Name
- CoolSeal Generator EUDAMEDElectrosurgical Generator FDA UDI
- Model / Reference
- CSL-200-50 EUDAMEDFDA UDI
- Description
- Electrosurgical Generator FDA UDI
Identifiers
- Catalog Number
- CSL-200-50 FDA UDI
- Primary DI / UDI-DI
- 00850346007023 EUDAMEDFDA UDI
- Basic UDI-DI
- 0850346007GSSGEN3M EUDAMED
- Direct Marketing DI
- 00850346007023 EUDAMED
- 510(k) Number
- K202114 FDA UDI
- FDA Product Code
- GEI FDA UDI
- EMDN Code
- Z12010905 RADIOSURGICAL UNITS EUDAMED
- GMDN Term
- Electrosurgical system generator 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
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Electrosurgical system generator
CoolSeal™ Generator by Justright Surgical — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Electrosurgical system generator.
- Cook — COOK INCORPORATED · Class II
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- Cook — COOK INCORPORATED · Class II
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- INTELLIO SHIFT — Smith & Nephew, Inc. · Class II
Cleared under the same submission
K202114 also covers:
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
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 e0ea0e61-f0a1-40c3-9edc-365af2f81fae 37 fields · synced Jul 24, 2026
- EUDAMED e602e743-af7f-4582-b6ff-607405bfeb4a 61 fields · synced Jul 24, 2026