Identity
- Trade Name
- ENSEAL EUDAMEDHarmonic FDA UDI
- Generic Name
- Open-surgery electrosurgical handpiece/electrode, bipolar, single-use FDA UDI
- Device Name
- ENSEAL X1 Tissue Sealer EUDAMEDENSEAL X1 STRAIGHT 37CM SHAFT FDA UDI
- Model / Reference
- NSLX137S EUDAMEDFDA UDI
- Description
- ENSEAL X1 STRAIGHT 37CM SHAFT FDA UDI
Identifiers
- Catalog Number
- NSLX137S FDA UDI
- Primary DI / UDI-DI
- 10705036015482 EUDAMEDFDA UDI
- Basic UDI-DI
- 0705036a0008578 EUDAMED
- 510(k) Number
- K201696 FDA UDI
- FDA Product Code
- HGI FDA UDIGEI FDA UDI
- EMDN Code
- K0201010201,K0201010202 EUDAMED
- GMDN Term
- Open-surgery electrosurgical handpiece/electrode, bipolar, single-use FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 884.4120 FDA UDI878.4400 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
Yes
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Enseal by Ethicon Endo-Surgery, LLC — Class IIb — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0705036a0008578 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Ethicon Endo-Surgery, LLC
- EUDAMED SRN
- US-MF-000013107
- Authorised Representative
- Johnson & Johnson Medical GmbH DE-AR-000007712
Sources (2)
- EUDAMED a5c8d357-09d3-47f7-bc1b-8fd7011d7f2c 61 fields · synced Jun 9, 2026
- FDA UDI bdf3d987-06a7-4cbf-92eb-41fe06e0c9e8 37 fields · synced May 30, 2026