Identity
- Trade Name
- CoolSeal Mini EUDAMEDCoolSeal™ Mini FDA UDI
- Generic Name
- Endoscopic electrosurgical handpiece/electrode, bipolar, single-use FDA UDI
- Device Name
- CoolSeal Mini EUDAMEDMaryland Laparoscopic Sealer FDA UDI
- Model / Reference
- CSL-MN103-20 EUDAMEDFDA UDI
- Description
- Maryland Laparoscopic Sealer FDA UDI
Identifiers
- Catalog Number
- CSL-MN103-20 FDA UDI
- Primary DI / UDI-DI
- 00850346007085 EUDAMEDFDA UDI
- Basic UDI-DI
- 0850346007GSSCSL-MND2 EUDAMED
- Direct Marketing DI
- 00850346007085 EUDAMED
- 510(k) Number
- K202114 FDA UDI
- 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 — 20 Centimeter FDA UDI
Category: Endoscopic electrosurgical handpiece/electrode, bipolar, single-use
CoolSeal™ Mini by Justright Surgical — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Cleared under the same submission
K202114 also covers:
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 154f7328-bcc6-4c28-9abc-6128ef497a34 38 fields · synced Jul 9, 2026
- EUDAMED d50a1d92-d5ab-4513-8495-3fa43c38f68a 61 fields · synced Jul 9, 2026